Label: HAND SANITIZER- ethyl 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 January 19, 2022

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  • Drug Facts

  • Active Ingredients:

    Ethyl Alcohol 62%

  • Purpose:

    Antiseptic

  • Uses:

    • hand sanitizer to decrease bacteria on the skin

    • recommended for repeated use

    • for use when soap and water are not available

  • WARNING:

    For External Use Only

    Do not apply in or around eyes. In case of contact, rinse eyes thoroughly with water. Avoid contact with broken skin. Do not inhale or ingest. Stop use and ask a doctor if irritation and redness develop and last for more than 72 hours. Get immediate medical help if swallowed.
    Flammable, keep away from fire or flame.

    Keep Out of Reach of Children

  • Directions:

    • wet hands thoroughly with product and allow to dry without wiping

    • supervise children under 6 years of age when using this product to avoid swallowing

  • Inactive Ingredients:

    Water, Glycerin, Essential Oils

  • SPL UNCLASSIFIED SECTION

    Distributed by: Golden Applexx STOPNGO Line Industry, CA 91789

    MADE IN USA

  • Packaging

    Hndstzr

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73742-101
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL0.62 mL  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73742-101-591 in 1 CARTON03/23/2020
    159 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A03/23/2020
    Labeler - Golden Applexx Co., Inc. (152634010)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Qiyu Commodity Co., Ltd.554518486manufacture(73742-101)
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