Label: ALCOSM HAND SANITIZER WIPES- alcohol cloth

  • 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 October 19, 2020

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  • Active Ingredient

    Ethanol Alcohol 70% by volume

    Purpose

    Antiseptic

  • USE

    for hand sanitizing to decrease bacteria on the skin

    apply topically to the skin to help prevent cross contamination

    not recommended for repeated use

    dries in seconds

  • Warning

    ●Flammable. Keep away from fire or flame. For
    external use only.
    ●Do not use in or contact the eyes.
    ●Stop use and ask a doctor if skin irritation or rash
    develops.

    Keep out of reach of children

    If swallowed, get medical help or call Poison Control Center immediately.

  • Directions

    .Open lid, gently pull back resealable label, remove and use wipe
    ·Reseal back after use to avoid evaporation of alcohol.
    other information
    .Store at room temperature 15°-30°C(59°-86°F).
    .Lot No. Manufacture date and Expiration date can be found
    on canister.

  • Inactive ingredients

    Aloe Barbadensis Leaf Juice,Carbormer,Diazolidinyl Urea,Glycerin,
    Methylparaben,Polysorbate 20,Propylene Glycol,Propylparaben,
    TocopherylAcetate,Triethanolamine,Water.

  • PRINCIPAL DISPLAY PANEL

    1

  • INGREDIENTS AND APPEARANCE
    ALCOSM HAND SANITIZER WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75109-518
    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
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75109-518-01135 in 1 PAIL10/20/2020
    1330.4 mL in 1 NOT APPLICABLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/20/2020
    Labeler - Kangna (Zhejiang) Medical Supplies Co., Ltd. (554530173)
    Establishment
    NameAddressID/FEIBusiness Operations
    Kangna (Zhejiang) Medical Supplies Co., Ltd.554530173manufacture(75109-518)
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