Label: 75% ALCOHOL 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 February 13, 2023

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

  • ACTIVE INGREDIENT

    Alcohol 75% v/v. Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    For hand sannitizing to reduce bacteria on the skin.

  • WARNINGS

    Flammable. Keep away from fire or flame. For external use only.

  • WHEN USING

    Keep away from eyes.

  • KEEP OUT OF REACH OF CHILDREN

    Keep our of reach of children.

  • DO NOT USE

    Do not inhale or ingest.

  • STOP USE

    Stop use and ask doctor if irritation or redness develops.

  • DOSAGE & ADMINISTRATION

    Squeeze small amount in your palm and briskly rub hands together and allow to air dry.

    For children under 6, use with adult supervision.

    Not recommended for infants.

  • OTHER SAFETY INFORMATION

    Store below 105F (43C). May discolor certain fabrics or surfaces.

  • INACTIVE INGREDIENT

    Water, Acrylic Polymer, Triethanolamine, Glycerine.

  • Package Label - Principal Display Panel

    237 mL NDC: 74621-001-04

    PDP

  • INGREDIENTS AND APPEARANCE
    75% ALCOHOL HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75690-001(NDC:74621-001)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL75 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    CARBOMER 940 (UNII: 4Q93RCW27E)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75690-001-01237 mL in 1 BOTTLE; Type 0: Not a Combination Product04/21/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/21/2020
    Labeler - Pinnacle Brands LLC (117150686)
    Registrant - Aogrand International Trade Corporation (421353092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aogrand International Trade Corporation421353092manufacture(75690-001) , relabel(75690-001)