Label: ALCOHOL- hand safe hand sanitizer gel 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 January 13, 2022

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  • ACTIVE INGREDIENT

    Alcohol

  • ASK DOCTOR

    Ask a Doctor

  • Use

    Use - For hand-washing to decrease bacteria on the skin, only when water is not available.

  • Purpose

    Antiseptic

  • Stop Use

    irritation and redness develop

  • Warning Section

    Flammable, keep away from fire and flames. For external use only.

  • Directions

    Wet hands thoroughly with product and allow to dry without wiping.

  • Keep out of reach of children

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

  • Inactive Ingredients

    Glycerin, carbopol, water, propylene glycol, fragrance

  • Label

    Label

  • INGREDIENTS AND APPEARANCE
    ALCOHOL 
    hand safe hand sanitizer gel gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:67285-104
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL80 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 9.4 g  in 100 mL
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC) 0.4 g  in 100 mL
    ALOE VERA LEAF (UNII: ZY81Z83H0X) 0.2 g  in 100 mL
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 5 g  in 100 mL
    GLYCERIN (UNII: PDC6A3C0OX) 5 g  in 100 mL
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q) 0.25 g  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:67285-104-0259 mL in 1 BOTTLE, DISPENSING; Type 0: Not a Combination Product07/02/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/02/2020
    Labeler - Relief-Mart, Inc (124312344)
    Establishment
    NameAddressID/FEIBusiness Operations
    Generitech Corporation138352435manufacture(67285-104)