Label: HAND SANITIZER- alcohol gel

  • 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 27, 2020

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  • ACTIVE INGREDIENT

    Ethyl alcohol 70% v/v

  • PURPOSE

    Antiseptic

  • INDICATIONS & USAGE

    • Hand Sanitizer to help reduce bacteria on the skin
    • For use when soap and water are not available
    • Recommended for repeated use
  • WARNINGS

    For external use only

    Flammable. Keep away from heat or flame

  • DO NOT USE

    Do not use:

    • In children less than 2 months of age
    • On open skin wounds
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medical help or contact poison control center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    Place enough product on hands to cover all surfaces. Rub hands together until dry. Supervise children under 6 years in the use of this product.

  • OTHER SAFETY INFORMATION

    Store between 15-30C (59-86F)

    Avoid freezing and excessive heat above 40C (104F)

  • INACTIVE INGREDIENT

    Aminoethyl Propanol, Acrylates Copolymer, Glycerin, Hydrogen Peroxide, Purified Water, Fragrance

  • PRINCIPAL DISPLAY PANEL

    5L

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78319-007
    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
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78319-007-015000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product07/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/01/2020
    Labeler - Pafer Foods & Beverages, S. de R.L de C.V. (812764102)
    Registrant - Pafer Foods & Beverages, S. de R.L de C.V. (812764102)
    Establishment
    NameAddressID/FEIBusiness Operations
    Pafer Foods & Beverages, S. de R.L. de C.V.812764102pack(78319-007) , label(78319-007)
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