Label: GNC INSTANT HAND SANITIZER- alcohol gel

  • NDC Code(s): 43655-1111-0, 43655-1111-1
  • Packager: GNC Holdings LLC
  • 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 31, 2023

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  • Active ingredient

    Ethyl Alcohol 66.5%

  • Purpose

    Antiseptic

  • Uses

    • hand sanitizer to help reduce bacteria on hands and skin
    • recommended for repeated use
  • Warnings

    For external use only

    Flammable, keep away from fire or flames

    Do not use in the eyes. If this happens, rinse thoroughly with water

    Stop use and ask a doctor if irritation and redness develop and persists

    Keep out of reach of children

    If ingested get medical help or contact a Poison Control Center right away

  • Directions

    • wet hands thoroughly with product
    • allow to dry without wiping
    • children under 6 should be supervised while using this product
  • Inactive ingredients

    Purified Water, Carbomer, Aloe Vera, Triethanolamine, Fragrance, D&C Green #5, D&C Yellow #10

  • Principal Display Panel - 118 mL Bottle Label

    GNC
    LIVE WELL

    hand
    sanitizer

    Ethyl Alcohol 66.5%

    FRESH SCENT

    NDC 43655-1111-0

    4.0 FL. OZ. (118 mL)

    Principal Display Panel - 118 mL Bottle Label
  • Principal Display Panel - 237 mL Bottle Label

    GNC
    LIVE WELL

    hand
    sanitizer

    Ethyl Alcohol 66.5%

    FRESH SCENT

    NDC 43655-1111-1

    8.0 FL. OZ. (237 mL)

    Principal Display Panel - 237 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    GNC INSTANT HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43655-1111
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL66.5 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    D&C GREEN NO. 5 (UNII: 8J6RDU8L9X)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-1111-0118 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2021
    2NDC:43655-1111-1237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/01/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/01/2021
    Labeler - GNC Holdings LLC (117772252)
    Registrant - Safetec of America, Inc. (874965262)
    Establishment
    NameAddressID/FEIBusiness Operations
    Safetec of America, Inc.874965262MANUFACTURE(43655-1111)
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