Label: GOLDEN GROOMING COMPANY 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 November 30, 2020

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  • Drug Facts

  • Active Ingredient(s)

    ethyl alcohol 70% v/v

  • Purpose

    Antiseptic

  • INDICATIONS & USAGE

    Use(s) Hand sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warning

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

    Do not use:

    ■ in children less than 2 months of age

    ■ on open skin wounds

    When using this product keep out of eyes, ears, and mouth. In case of contact with eyes, rinse eyes thoroughly with water.

    Stop use and ask a doctor if irritation or rash occurs. These may be signs of a serious condition.

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

  • Directions

    ■ Place 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 15-30C (59-86F)

    ■ Avoid freezing and excessive heat above 40C (104F)

  • Inactive Ingredients

    water, glycerin, PEG-6 (AND) AMP-acrylates/vinyl isodecanoate crosspolymer, fragrance, aloe barbadensis (aloe vera) leaf juice, tocopheryl acetate (vitamin E acetate)

  • SPL UNCLASSIFIED SECTION

    70% ETHYL ALCOHOL GEL

    WITH MOISTURIZING ALOE & VITAMIN E

    Squeeze a bead of gel into your palm large enough to cover your whole hands, including between your fingers and around your thumbs. People are always forgetting those areas.

    Made in USA

    Visit us at: goldengroomingco.com

    Manufactured for Golden Grooming by:

    Square M LLC

    Sterling Heights, MI 48314

  • Packaging

    IMAGEIMAGE

  • INGREDIENTS AND APPEARANCE
    GOLDEN GROOMING COMPANY HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:73834-202
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL70 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    VINYL NEODECANOATE (UNII: 9NDY01YYPT)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:73834-202-16474 mL in 1 BOTTLE; Type 0: Not a Combination Product06/06/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/06/2020
    Labeler - Square M Llc (117467455)
    Establishment
    NameAddressID/FEIBusiness Operations
    Square M Llc117467455manufacture(73834-202)
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