Label: 65% ALCOHOL HAND SANITIZER (NO WATER)- 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 December 31, 2021

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

  • ACTIVE INGREDIENT

    Alcohol 65% v/v. Purpose: Antiseptic

  • PURPOSE

    Antiseptic, Hand Sanitizer

  • INDICATIONS & USAGE

    HELPS REDUCE BACTERIA ON THE SKIN. RECOMMENDED FOR REPEATED USE.

  • DOSAGE & ADMINISTRATION

    SQUEEZE A SMALL AMOUNT INTO THE PALMS OF YOUR HANDS AND MASSAGE GENTLY. ALLOW TO DRY WITHOUT WIPING OR RINSING.

  • WARNINGS

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

  • WHEN USING

    When using this product, avoid contact with eyes. In case of contact with eyes, flush thoroughly with water. Avoid contact with broken skin.

  • STOP USE

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

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

  • INACTIVE INGREDIENT

    Water, Carbomer 940, Triethanolamine, Glycerin

  • OTHER SAFETY INFORMATION

    Store below 110 (Degree Fahrenheit). May cause discoloration to certain fabrics and surfaces.

  • Package Label - Principal Display Panel

    236 mL NDC: 74642-001-01

    PDP

  • INGREDIENTS AND APPEARANCE
    65% ALCOHOL HAND SANITIZER (NO WATER) 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:74642-001(NDC:74621-003)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    ACRYLIC ACID (UNII: J94PBK7X8S)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:74642-001-01236 mL in 1 BOTTLE; Type 0: Not a Combination Product04/18/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/18/2020
    Labeler - Virgin Scent Inc. (034474058)
    Registrant - Aogrand International Trade Corporation (421353092)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aogrand International Trade Corporation421353092manufacture(74642-001) , relabel(74642-001)