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 May 13, 2020

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  • Active Ingredients

    Alcohol 62% v/v

  • Purpose

    Antiseptic

  • Use

    ■ hand sanitizer to help reduce bacteriaon the skin. For use when soap and water are not available.

  • Warnings

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

  • When using this product

    ■ keep out of eyes, ears, and mouth. ■ in case of eye contact immediately flush eyes thoroughly with water.

  • Stop use and ask a doctor if

    ■ irritation or redness develops ■ conditions persist for more than 72 hours

  • Keep out of reach of children

    In case of accidental ingestion, contact a doctor or Poison Control Center immediately.

  • Directions

    ■ Squeeze enough product on hands to cover all surfaces ■ rub hands together until dry ■ Supervise children under 6 years of age when using this product to avoid swallowing

  • Other information

    ■ Store between 15-30 C (59-86F) ■ may discolor fabrics or surfaces

  • Inactive ingredients

    Water, Carbomer, Aminomethyl Propanol

  • Package Label

    package label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76750-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76750-002-0130 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/2020
    2NDC:76750-002-0260 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product05/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/06/2020
    Labeler - Global Marketing Products LLC (106075178)
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