Label: 62% ALCOHOL HAND SANITIZER- hand sanitizer 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 December 23, 2021

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  • PURPOSE

    Disinfection
    Sterilization
    No Rinseing

  • ACTIVE INGREDIENT

    Alcohol62%

  • INDICATIONS & USAGE

    Directions: Pour a sufficient amount of the liquid into the palm of your dry hands. Rub thoroughly all over hands briskly until dry. Repeat if necessary. Use without water. Use only under adult supervision.

  • KEEP OUT OF REACH OF CHILDREN

  • WARNINGS

    Warnings: Highly flammable liquid and vapour. Causes serious eye iritation. May cause skin iritation. Keep away from heat, sparks, hot surfaces, fire, open flame and sources of ignition. No smoking. Keep at room temperature. Store in a well-ventilated, cool and dry place, away from direct sunlight. Do not store above 40 °C

    For external use only.

    Avoid contact with eyes. If in eyes, rinse immediately with clean water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Do not swallow. If swallowed, rinse mouth and seek medical advice immediately and show this label. Do not induce vomiting. Do not use on damage, inflamed or broken skin. If iritation or redness develops, discontinue use.

    Keep out of the reach of babies, children & animals.

  • DOSAGE & ADMINISTRATION

    236ml store in ventilated shade and Do not store above 40 °C

  • INACTIVE INGREDIENT

    Alcohol, water/eau/aqua, carbomer，triethanolamine, propylene glycol, glycerin

  • Front Panel and Back Panel Art

    label

  • INGREDIENTS AND APPEARANCE
    62% ALCOHOL HAND SANITIZER 
    hand sanitizer gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78495-015
    Route of AdministrationEXTRACORPOREAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL146.32 mL  in 236 mL
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78495-015-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/14/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E04/07/2020
    Labeler - Ultra Distributors Inc (007160073)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ultra Distributors007160073relabel(78495-015)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Home Solution Corp., LTD679868836manufacture(78495-015)
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