Label: ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID- benzalkonium chloride, aspirin, ibuprofen, isopropyl alcohol, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen, diphenhydramine chloride kit

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated January 11, 2011

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • ACTIVE INGREDIENT

    Active Ingredient: .........Bacitracin Zinc 400 units

    Neomycin Sulfate 5mg ( equivalent to 3.5 mg Neomycin base)

    Polymyxin B Sulfate 5000 units

  • PURPOSE

    Uses:  To help prevent infection in:
    minor cuts;  scrapes;  burns

  • WARNINGS

    Warnings:

    For external use only.

  • DO NOT USE

    Do not use:  in eyes;  over large areas of the body;

    If allergic to any of the ingredients;  for more than one week unless directed by a physician.

  • STOP USE

    Stop use and consult a doctor:

    if the condition persists or gets worse;  a rash or other allergic reaction develops

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If ingested, contact a Poison

    Control Center right away.

  • WHEN USING

    Directions: clean affected area;  apply small amount of this product (an amount equal to the surface area of the tip of a finger) on the area 1 to 3 times daily; may be covered with a sterile bandage

  • STORAGE AND HANDLING

    Other information:

    Store at room temperature.

  • PRINCIPAL DISPLAY PANEL

    Genuine Triple Antibiotic

    First Aid Ointment

    To Help Prevent Infection

    Each Gram Contains:

    Bacitracin Zinc 400 units

    Neomycin Sulfate 5 mg

    (equivalent to 3.5 mg

    Neomycin base)

     Polymyxin B Sulfate 5000 units

    Net Wt. 0.5g ; (1/64 oz)

    Manufactured in CHINA for

    GENUINE FIRST AID.

  • ACTIVE INGREDIENT

    Active Ingredient:                           Purpose:

    Benzocaine, 6% w/v..................    Topical Anesthetic

    SD alcohol, 60% w/v..................   Antiseptic

  • PURPOSE

    Use: For the temporary relief of pain and itching associated with minor burns, scrapes and insect bites.

  • WARNINGS

    Warnings: For external use only.

    Avoid contact with eyes.  If this happens, rinse thoroughly with water.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  If swallowed, get medical help or contact a Poison Control Center right away.

  • STORAGE AND HANDLING

    Flammable - keep away from fire or flame.

  • DO NOT USE

    Do not use: In eyes, on broken skin, deep puncture wounds.  If unusual redness, swelling, irritation or other symptoms occur, consult a physician immediately.

  • DESCRIPTION

    Made in CHINA

    LOT/EXP:

  • PRINCIPAL DISPLAY PANEL

    Insect Sting Relief Pad


    Genuine First Aid LLC, Clearwater FL 33755
                            www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID
  • ACTIVE INGREDIENT


    Active ingredient (in each tablet)                       Purpose

    Ibuprofen USP (NSAID*) 200mg . . . . . . . . . . . .Pain reliever/fever reducer

    *nonsteroidal anti-inflammatory drug

  • PURPOSE


    Uses temporarily relieves minor aches and pains due to:

    the common cold

    headache

    toothache

    muscular aches

    backache

    minor pain of arthritis

    menstrual cramps temporarily reduces fever
  • WARNINGS



    Warnings

    Allergy alert: Ibuprofen may cause a severe allergic reaction, especially in people allergic to aspirin. Symptoms may include: shock,  facial swelling,  asthma (wheezing) rash, skin reddening, blisters, hives If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning: This product contains a nonsteroidal anti-inflammatory drug (NSAID), which may cause severe stomach
    bleeding. The chance is higher if you: are age 60 or older, have had stomach ulcers or bleeding problems, take a blood thinner (anticoagulant) or steroid drug, take other drugs containing NSAIDs (aspirin, ibuprofen, naproxen, or others), have 3 or more alcoholic drinks every day while using this product, take more or for a longer time than directed
  • DO NOT USE


    Do not use if you have ever had an allergic reaction to any other pain reliever/fever reducer,  right before or after heart surgery.

  • ASK DOCTOR

    Ask a doctor before use if  stomach bleeding warning applies to you; you have a history of stomach problems such as heartburn; you have a high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic
  • ASK DOCTOR/PHARMACIST


    Ask a doctor before use if you are:
    taking any other drug containing NSAID (prescription or nonprescription); taking aspirin for heart attack or stroke, because Ibuprofen may decrease this benefit of aspirin; taking any other drug
  • WHEN USING

    When using this product:
    take with food or milk if stomach upset occurs
  • STOP USE

    Stop use and ask a doctor If:
    you experience any of the following signs of stomach bleeding; feel faint; vomit blood; have bloody or black stools; have stomach pain that does get better; pain gets worse or lasts more than 10 days; fever gets worse or lasts more than 3 days; redness or swelling is present in the painful area; any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important not to use ibuprofen during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
  • DOSAGE & ADMINISTRATION

    Directions:
    do not use more than directed; the smallest effective dose should be used; do not take longer than 10 days, unless directed by a doctor.

    Adults and Children (12 years and older):  Take 1 tablet every 4 to 6 hours while symptoms persist.  If pain or fever does not respond to 1 tablet, 2 tablets may be used.  Do not exceed 6 tablets in 24 hours, unless directed by a doctor.

    Children under 12 years: Do not give to children under 12 years of age.


  • STORAGE AND HANDLING


    Other information:  Store at controlled room temperature; avoid excessive heat 40 degree Celsius (104 degree Fahrenheit); tamper evident sealed packets; do not use any opened or torn packets
  • INACTIVE INGREDIENT

    Inactive ingredients: cellulose, corn starch, fumed silica gel, hypromellose, lactose, magnesium stearate, polydextrose, polyethylene glycol, povidone, silica, sodium starch glycolate, stearic acid, titanium dioxide, triacetin.

  • DESCRIPTION

    Distributed by GENUINE FIRST AID
    600 Cleveland Str Suite 400, Clearwater, FL 33755

  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN 2 Tablets

  • PRINCIPAL DISPLAY PANEL

    IBUPROFEN   2 Tablets

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                      Purpose

    Aspirin (NSAID*) 325 mg...............................   Pain Reliever / fever reducer

    *nonsteroidal anti-inflammatory drug 

  • PURPOSE

    Uses   Temporarily relieves minor aches and pains associated with:
    headache ; muscular aches ; minor arthritis pain ; backache ; common cold ; toothache ; menstrual cramps ; Temporarily reduces fever

  • WARNINGS

    Warnings

    Reye's syndrome:  Children and teenagers who have or are recovering from chicken pox of flu-like symptoms should not use this product.  When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

    Allergy alert:   Aspirin may cause a severe allergic reaction which may include:  hives, skin reddening, facial swelling, rash,  asthma (wheezing), blisters, shock, If an allergic reaction occurs, stop use and seek medical help right away.

    Stomach bleeding warning:   This contains an NSAID, which may cause severe stomach bleeding.  The chance is higher if you:
    are age 60 or older; have had stomach ulcers or bleeding problems; take a blood thinner (anticoagulant) or steroid drug; take other drugs containing prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others); have 3 or more alcoholic drinks every day while using this product; take more or for a longer time than directed

  • DO NOT USE

    Do not use:  if you have ever had an allergic reaction to any other pain reliever/ fever reducer; right before or after heart surgery; if you are taking a prescription drug for gout, diabetes or arthritis

  • ASK DOCTOR

    Ask a doctor before use if: stomach bleeding warning applies to you;  you have a history of stomach problems such as heartburn; you have high blood pressure, heart disease, liver cirrhosis, or kidney disease; you are taking a diuretic

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are:

    under a doctor's care for any serious condition;  taking any other drug

  • WHEN USING

    When using this product: take with food or milk if stomach upset occurs

  • STOP USE


    Stop use and ask a doctor if
    you experience any of the following signs of stomach bleeding:
    feel faint;  vomit blood; have bloody or black stools; have stomach
    pain that does not get better; pain gets worse or lasts more than 10 days;  fever gets worse or lasts more than 3 days; you have difficulty swallowing; if ringing in the ears or loss of hearing occurs; redness or swelling is present in the painful areas; any new symptoms appear
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use. It is especially important to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of overdose, get medical help or

    contact a Poison Control Center right away.

  • WHEN USING

    Directions

    do not use more than directed

    the smallest effective dose should be used

    drink a full glass of water with each dose

    do not take longer than 10 days, unless directed by a doctor


  • DOSAGE & ADMINISTRATION

    Adults and children: (12 years and older) Take 1 or 2 tablets with

    water every 4 hours as needed.  Do not take more than 12 tablets in 24

    hours, or as directed by a doctor.

    Children under 12 years:   Do not give to children under 12 years of age.

  • STORAGE AND HANDLING

    Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); avoid

    excessive heat and humidity;  tamper evident sealed packets;

    Do not use any opened or torn packets

  • INACTIVE INGREDIENT

    Inactive Ingredients:  hypromellose, polyethylene glycol, propylene glycol, corn starch

  • DESCRIPTION

    Distributed by GENUINE FIRST AID
    600 Clevelad Str Suite 400, Clearwater, FL 33755
  • PRINCIPAL DISPLAY PANEL

    ASPIRIN 2 Tablets
  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                      Purpose

    Acetaminophen 500 mg...............................   Pain Reliever / fever reducer


  • PURPOSE

    Purpose: Pain reliever, fever reducer

  • INDICATIONS & USAGE

    Uses   for the temporary relief of minor aches and pains associated with
    headache ; muscular aches ; minor arthritis pain ; toothache ; common cold ; menstrual cramps ; for the reduction of fever

  • WARNINGS

    Warnings

    Liver Warning: This product contains acetaminophen. Sever liver damage may occur if you take: more than 8 tablets in 24 hours, which is the maximum daily amount; with other drugs containing acetaminophen; 3 or more alcoholic drinks every day while using this product.

  • DO NOT USE

    Do not use:  with any other drug containing acetaminophen (prescription or non prescription). If you are not sure whether a drug contains acetaminiophen, ask a doctor or phramacist.
    for more than 10 days for pain unless directed by a doctor
    for more than 3 days for fever unless directed by a doctor

  • ASK DOCTOR

    Ask a doctor before use if you have liver disease

  • ASK DOCTOR/PHARMACIST

    Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin

    Stop using and ask a doctor if
    symptoms do not improve
    new symptoms occur
    pain or fever persists or gets worse
    redness or swellign is present

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.  In case of accidental overdose, get medical help or contact a Poison Control Center right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.

  • DOSAGE & ADMINISTRATION

    Adults and children: (12 years and older)
    take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours.

    Children under 12 years:
    do not give to children under 12 years of age.

  • STORAGE AND HANDLING

    Store at 59 - 86  degree Fahrenheit (15 - 30 degree Celsius); Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

  • INACTIVE INGREDIENT

    Inactive Ingredients:Cellulose*, corn starch*, crospovidone*, hydroxypropyl cellulose*, hypromellose*, magnesium stearate*, microcrystalline cellulose*, mineral oil*, opadry clear*, polyethylene glycol*, polyvinylpyrrolidone*, povidone*, pregelatinized starch*, propylene glycol*, silicon dioxide*, sodium carboxymethylcellulose*, sodium starch glycolate*, starch 1500*, stearic acid, talc*, titanium dioxide*, triacetin*.

  • ACTIVE INGREDIENT

    Active Ingredient (in each tablet)                      Purpose

    Diphenhydramine Hydrochloride 25mg...............................   Antihistimine


  • PURPOSE

    Purpose: Antihistimine

  • INDICATIONS & USAGE

    Uses   Temporarily relieves the following symptoms associated with hay fever or other upper respiratory allergies:
    runny nose, sneezing, itching of the nose or throat, itchy, watery eyes

  • STORAGE AND HANDLING

    Store at room temperature. Tamper-evident sealed packets. do not use any opened or torn packets Mfd. for MEDIQUE PRODUCTS, FORT MYERS, FL 33967

  • WARNINGS

    Warnings

    Ask a doctor before use
    if you have:
    a breathing problem such as emphysema or chronic bronchitis
    glaucoma
    difficulty in urination due to enlargement of the prostate gland

    if you are:
    taking any drugs for asthma
    taking sedatives or tranquilizers

  • WHEN USING

    When using this product

    Drowsiness may occur

    avoid alcoholic beverages

    alcohol, sedatives, and tranquilizers may increase the drowsiness effect

    use caution when driving a motor vehicle or operating machinery

    excitaility may occur, especially in children

  • KEEP OUT OF REACH OF CHILDREN

    Do not exceed recommended dosage. Keep this and all drugs out of the reach of children. In case of accidental overdose, contact a physician or posion control center immediately. As with any drug, if you are pregnant or nursing a baby, seek the advice of a health professional before using this product.

  • DOSAGE & ADMINISTRATION

    Adults and children: (12 years and older)
    take 1 capsule every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours, or as directed by a doctor.

    Children under 12 years:
    do not give to children under 12 years of age unless directed by a doctor.

  • INACTIVE INGREDIENT

    Inactive Ingredients:DandC Red 28, FDandC Blue 1, FDandC Red 40, gelatin, starch

  • ACTIVE INGREDIENT

    Active Ingredient:                                 Purpose

    Benzalkonium Chloride 0.40%..........   First Aid Antiseptic

  • PURPOSE

    Use: For Professional and Hospital use.  Helps prevent infection.  Antiseptic cleansing of face, hands and body without soap and water.

  • WARNINGS

    Warning:   For external use only.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children:  If swallowed, get medical help or contact a Poison Control Center right away.

  • STOP USE

    Stop use if unusual redness, swelling or other symptoms occur. Consult a physician immediately.

  • DO NOT USE

    Do not use in the eyes or over large areas of the body.

  • WHEN USING

    Directions: Tear open packet, unfold towelette and use to cleanse desired skin area.  Discard towelette appropriately after single use.


  • INACTIVE INGREDIENT

    Inactive Ingredient:   Purified water


  • DESCRIPTION

    LOT/EXP:                           Made in CHINA

    20130301

  • PRINCIPAL DISPLAY PANEL

    Antiseptic Towelette

    Genuine First Aid LLC, Clearwater FL 33755

    www.GenuineFirstAid.com

    1/pouch

    GENUINE FIRST AID

  • PRINCIPAL DISPLAY PANEL

    AntisepticTowelette
  • PRINCIPAL DISPLAY PANEL

    Insect Sting Relief Pad

  • PRINCIPAL DISPLAY PANEL

    GenuineTripleAntibiotic

  • PRINCIPAL DISPLAY PANEL

    Ibuprofen 200mg

  • PRINCIPAL DISPLAY PANEL

    Aspirin 325 mg
  • PRINCIPAL DISPLAY PANEL

    APAP_PDP
  • PRINCIPAL DISPLAY PANEL

    apap_pdp
  • PRINCIPAL DISPLAY PANEL

    DIPHEN_PDP
  • PRINCIPAL DISPLAY PANEL

    DIPHEN_PANEL
  • PRINCIPAL DISPLAY PANEL

    ONEPERSONKIT_FRONT
  • PRINCIPAL DISPLAY PANEL

    ONEPERSONKIT_BACK
  • INGREDIENTS AND APPEARANCE
    ADVENTURE MEDICAL KITS 1-2 PERSON FIRST AID  
    benzalkonium chloride, aspirin, ibuprofen, isopropyl alcohol, benzocaine, sd alcohol, bacitracin zinc, neomycin sulfate, polymyxin b sulfate, acetaminophen, diphenhydramine chloride kit
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:44224-2000
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:44224-2000-11 in 1 KIT
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 12 TUBE 1 g
    Part 22 PACKAGE 1 mL
    Part 34 PACKET
    Part 42 PACKET
    Part 53 PACKET
    Part 62 PACKAGE
    Part 710 PACKAGE 8 mL
    Part 1 of 7
    GENUINE TRIPLE ANTIBIOTIC  
    bacitracin zinc,neomycin sulfate,polymyxin b sulfate ointment
    Product Information
    Item Code (Source)NDC:52124-0003
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BACITRACIN ZINC (UNII: 89Y4M234ES) (BACITRACIN - UNII:58H6RWO52I) BACITRACIN ZINC400 [iU]  in 1 g
    NEOMYCIN SULFATE (UNII: 057Y626693) (NEOMYCIN - UNII:I16QD7X297) NEOMYCIN SULFATE5 mg  in 1 g
    POLYMYXIN B SULFATE (UNII: 19371312D4) (POLYMYXIN B - UNII:J2VZ07J96K) POLYMYXIN B SULFATE5000 [iU]  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0003-1.5 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333B08/26/2010
    Part 2 of 7
    INSECT STING RELIEF PAD  
    benzocaine,alcohol swab
    Product Information
    Item Code (Source)NDC:52124-0008
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5) BENZOCAINE6 mL  in 100 mL
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL60 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0008-10.5 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34808/26/2010
    Part 3 of 7
    IBUPROFEN  
    ibuprofen tablet
    Product Information
    Item Code (Source)NDC:52124-0009
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IBUPROFEN (UNII: WK2XYI10QM) (IBUPROFEN - UNII:WK2XYI10QM) IBUPROFEN200 mg
    Inactive Ingredients
    Ingredient NameStrength
    POWDERED CELLULOSE (UNII: SMD1X3XO9M)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE (UNII: J2B2A4N98G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUNDSize10mm
    FlavorImprint Code 44;352
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0009-12 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07501008/26/2010
    Part 4 of 7
    MEDIQUE DIPHEN 
    diphenhydramine hydrochloride capsule
    Product Information
    Item Code (Source)NDC:47682-182
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M) DIPHENHYDRAMINE HYDROCHLORIDE25 mg
    Inactive Ingredients
    Ingredient NameStrength
    GELATIN (UNII: 2G86QN327L)  
    D&C RED NO. 28 (UNII: 767IP0Y5NH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorpink (PINK) , white (WHITE) Scoreno score
    ShapeCAPSULESize14mm
    FlavorImprint Code CPC;835
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-182-461 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34108/25/2010
    Part 5 of 7
    MEDIQUE APAP EXTRA STRENGTH  
    acetaminophen tablet, film coated
    Product Information
    Item Code (Source)NDC:47682-175
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
    Inactive Ingredients
    Ingredient NameStrength
    CROSPOVIDONE (UNII: 68401960MK)  
    HYDROXYPROPYL CELLULOSE (UNII: RFW2ET671P)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    Colorwhite (WHITE) Scoreno score
    ShapeROUNDSize12mm
    FlavorImprint Code AZ;235
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47682-175-462 in 1 PACKET
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34308/26/2010
    Part 6 of 7
    ASPIRIN  
    aspirin tablet
    Product Information
    Item Code (Source)NDC:52124-0011
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASPIRIN (UNII: R16CO5Y76E) (ASPIRIN - UNII:R16CO5Y76E) ASPIRIN325 mg
    Inactive Ingredients
    Ingredient NameStrength
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    Product Characteristics
    Colorwhite (white) Scoreno score
    ShapeROUNDSize11mm
    FlavorImprint Code 44;157;ASPIRIN
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0011-12 in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart34308/26/2010
    Part 7 of 7
    ANTISEPTIC TOWELETTE  
    benzalkonium chloride swab
    Product Information
    Item Code (Source)NDC:52124-0001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7) (BENZALKONIUM - UNII:7N6JUD5X6Y) BENZALKONIUM CHLORIDE0.40 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52124-0001-10.8 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart333E09/09/2010
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333B08/26/2010
    Labeler - Tender Corp dba Adventure Medical Kits (064437304)
    Registrant - GFA Production (Xiamen) Co., Ltd. (421256261)
    Establishment
    NameAddressID/FEIBusiness Operations
    GFA Production (Xiamen) Co., Ltd.421256261manufacture