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 28, 2020

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

    Help decrease bacteria on skin.

    Recommended for repeated use

  • WARNINGS

    For external use only

    Flammable, keep away from fire or flame

    Do not apply around eyes.

  • WHEN USING

    When using this product, avoid contact with eyes. In case of contact, flush eyes with water.

  • STOP USE

    Stop use and ask a doctor if irritation or redness develops & condition persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep our of reach of Children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    Pump as needed into your palms & thoroughly spread on both hands.

  • OTHER SAFETY INFORMATION

    Do not store above 110F

  • INACTIVE INGREDIENT

    Water, Glycerin, Triethanolamine, Carbomer, Dimethylamino

  • Package Label - Principal Display Panel

    60 mL NDC: 74235-001-01

    PDP

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74235-001(NDC:74742-002)
    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
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    WATER (UNII: 059QF0KO0R)  
    DIMETHYLAMINE (UNII: ARQ8157E0Q)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74235-001-0160 mL in 1 BOTTLE; Type 0: Not a Combination Product04/29/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/29/2020
    Labeler - Quality Innovations Inc. (079258818)