Label: GNC ANTIMICROBIAL HAND WIPES- alcohol cloth

  • 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

  • Use

    • for sanitizing to decrease bacteria on skin when soap and water is not available
  • Warnings

    For external use only.

    Flammable, keep away from fire or flame

    Do not use

    • in the eyes, if contact occurs, rinse eyes thoroughly with water

    Stop use and ask a doctor if

    • irritation or redness develop and persists

    Keep out of reach of children. If swallowed get medical help or contact a Poison Control Center right away

  • Directions

    • tear open packet and remove towelette
    • wipe hand, finger and wrist areas thoroughly with towelette for 15 seconds
    • dispose of used towelette properly
    • children under 6 years of age should be supervised when using this product
  • Inactive Ingredients

    Purified Water, Aloe Vera, Triethanolamine, Fragrance

  • Principal Display Panel – Carton Label

    NDC 43655-3111-0

    GNC
    LIVE WELL

    Antimicrobial
    hand wipes

    Ethyl Alcohol 66.5%

    FRESH SCENT

    25 PRE-MOISTENED TOWELETTES

    Principal Display Panel – Carton Label
  • Principal Display Panel – Pouch Label

    NDC 43655-3111-0

    GNC
    LIVE WELL

    Antimicrobial
    hand wipes

    Ethyl Alcohol 66.5%

    FRESH SCENT

    1 PRE-MOISTENED TOWELETTE

    Principal Display Panel – Pouch Label
  • INGREDIENTS AND APPEARANCE
    GNC ANTIMICROBIAL HAND WIPES 
    alcohol cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:43655-3111
    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)  
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:43655-3111-025 in 1 BOX05/01/2021
    11.7 mL in 1 POUCH; Type 0: Not a Combination Product
    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(43655-3111)
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