Label: DISINFECTING WIPES- alcohol cloth

  • Contains inactivated NDC Code(s)
    NDC Code(s):
    79455-002-01, 79455-002-02, 79455-002-03, 79455-002-04, view more
    79455-002-05, 79455-002-06, 79455-002-07, 79455-002-08, 79455-002-09, 79455-002-10, 79455-002-11, 79455-002-12, 79455-002-13, 79455-002-14
  • Packager: NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 July 13, 2020

If you are a consumer or patient please visit this version.

  • Drug Facts

  • Active ingredient

    Ethanol Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to decrease bacteria on the skin
    • recommended for repeated use
    • for use when soap and water are not available
  • Warnings

    Flammable, keep away from fire/flame

    For external use only

    Do not use

    • in children less than 2 months of age
    • on open skin wounds

    When using this product • do not get into eyes. In case of contact, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation and redness develop
    • condition persists for more than 72 hours

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

  • Directions

    • wet hands thoroughly with product and allow to dry without wiping
    • supervise children under 6 years of age when using this product to avoid swallowing
  • Other information

    • store between 15-30C (59-86F)
    • avoid freezing and excessive heat above 40C (104F)
  • Inactive ingredients 

    10mg glycerin, 10mg Butylene glycol, 10mg Perfume, ,365mg Aqua 10 mg Lanolin

  • SPL UNCLASSIFIED SECTION

    Kills 99,99% of Germs

    Import Company:

    Hand Sanitizer, LLC

    On Time Inventory

    850 Kaliste Saloom Rd, Lafayette, La 70508.

    www.handsanitizerllc.com

    Manufactured: Necm Kimya Akaryakıt Ürünleri Medikal Malzemeler San. ve Tic. Ltd. Şti.

    COUNTRY OF ORIGIN TURKEY

    Open lid and pull out the first wipe.

    Pull wipe apart at the perforated seam.

    Keep container tighthy closed to keep wipes from drying out.

    Do Not Flush

  • Packaging

    WIPE1

  • INGREDIENTS AND APPEARANCE
    DISINFECTING WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:79455-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    WATER (UNII: 059QF0KO0R)  
    LANOLIN (UNII: 7EV65EAW6H)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:79455-002-011 in 1 PACKET07/13/2020
    15 mL in 1 PACKAGE; Type 0: Not a Combination Product
    2NDC:79455-002-0250 in 1 CONTAINER07/13/2020
    25 mL in 1 PACKAGE; Type 0: Not a Combination Product
    3NDC:79455-002-0370 in 1 CONTAINER07/13/2020
    35 mL in 1 PACKAGE; Type 0: Not a Combination Product
    4NDC:79455-002-0472 in 1 CONTAINER07/13/2020
    45 mL in 1 PACKAGE; Type 0: Not a Combination Product
    5NDC:79455-002-0580 in 1 CONTAINER07/13/2020
    55 mL in 1 PACKAGE; Type 0: Not a Combination Product
    6NDC:79455-002-06100 in 1 CONTAINER07/13/2020
    65 mL in 1 PACKAGE; Type 0: Not a Combination Product
    7NDC:79455-002-07120 in 1 CONTAINER07/13/2020
    75 mL in 1 PACKAGE; Type 0: Not a Combination Product
    8NDC:79455-002-08150 in 1 CONTAINER07/13/2020
    85 mL in 1 PACKAGE; Type 0: Not a Combination Product
    9NDC:79455-002-09200 in 1 PAIL07/13/2020
    95 mL in 1 PACKAGE; Type 0: Not a Combination Product
    10NDC:79455-002-10250 in 1 PAIL07/13/2020
    105 mL in 1 PACKAGE; Type 0: Not a Combination Product
    11NDC:79455-002-11350 in 1 PAIL07/13/2020
    115 mL in 1 PACKAGE; Type 0: Not a Combination Product
    12NDC:79455-002-12400 in 1 PAIL07/13/2020
    125 mL in 1 PACKAGE; Type 0: Not a Combination Product
    13NDC:79455-002-13750 in 1 PAIL07/13/2020
    135 mL in 1 PACKAGE; Type 0: Not a Combination Product
    14NDC:79455-002-141000 in 1 PAIL07/13/2020
    145 mL in 1 PACKAGE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/13/2020
    Labeler - NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI (355742649)
    Establishment
    NameAddressID/FEIBusiness Operations
    NECM KIMYA AKARYAKIT URUNLERI MEDIKAL MALZEMELER SANAYI VE TICARET LIMITED SIRKETI355742649manufacture(79455-002)