Label: GNA- alcohol gel

  • Category: HUMAN OTC DRUG LABEL

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 June 9, 2020

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  • Active Ingredient

    Ethyl Alcohol 70% v/v.

  • Purpose

    Antiseptic

  • Use

    Hand Sanitizer to help reduce bacteria that potentially can cause disease. For use when soap and water are not available.

  • Warnings

    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

    Keep out of reach of children. If swallowed, get medical help or contact a 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 15-300C (59-860F)
    • Avoid freezing and excessive heat above 400C (1040F)
  • Inactive ingredients

    Acrylate copolymer, glycerin, hydrogen peroxide,Triethanolamine , water. 

  • Package Label - Principal Display Panel

    :Label

  • INGREDIENTS AND APPEARANCE
    GNA 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76692-001
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    DIMETHYLAMINOETHYL METHACRYLATE - BUTYL METHACRYLATE - METHYL METHACRYLATE COPOLYMER (UNII: 905HNO1SIH)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    HYDROGEN PEROXIDE (UNII: BBX060AN9V)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76692-001-0160 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    2NDC:76692-001-02118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    3NDC:76692-001-03250 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    4NDC:76692-001-04473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    5NDC:76692-001-05946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    6NDC:76692-001-06208198 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    7NDC:76692-001-071040990 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    8NDC:76692-001-083785 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product06/05/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A06/05/2020
    Labeler - GREENSYS OF NORTH AMERICA LLC (075577393)
    Establishment
    NameAddressID/FEIBusiness Operations
    GREENSYS OF NORTH AMERICA LLC075577393manufacture(76692-001)
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