Label: HAPP HAND SANITIZER- alcohol gel

  • NDC Code(s): 76735-001-01, 76735-001-02, 76735-001-03, 76735-001-04
  • Packager: Fujian Happiness Biotech Technology Co., Ltd.
  • 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 July 2, 2020

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  • Active Ingredient

    Ethyl Alcohol 65% v/v.

  • Purpose

    Antiseptic

  • Uses

    • to decrease bacteria on the skin that could cause disease
    • recommended for repeated use
  • Warnings

    For external use only - hands

    • Flammable, keep away from heat and flame

    When using the product

    • keep out of eyes, in case of contact with eyes, flush thoroughly with water
    • avoid contact with broken skin
    • do not inhale or ingest

    Stop use and ask a doctor if skin irritation develops.

  • 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

    • Wet hand thoroughly and allow to dry without wiping
    • For children under 6, use only under adult supervision
    • not recommended for infants
  • Inactive ingredients

    Purified water, Glycerin, Polyacrylic acid, Aminomethylpropanol

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    HAPP HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76735-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL65 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
    WATER (UNII: 059QF0KO0R)  
    AMINOMETHYLPROPANOL (UNII: LU49E6626Q)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76735-001-0150 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    2NDC:76735-001-02100 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    3NDC:76735-001-03236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    4NDC:76735-001-04500 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product04/26/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A04/26/2020
    Labeler - Fujian Happiness Biotech Technology Co., Ltd. (527275979)