Label: ZAPIRE 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 May 30, 2020

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  • Drug Facts

  • Active ingredient

    Ethyl Alcohol 70%

  • Purpose

    Antiseptic

  • Uses

    • To decrease bacteria on the skin that could cause disease.
    • When water, soap and towel are not available.
    • Recommended for repeated use.
  • Warnings

    For external use only: hands.

    Flammable. Keep away from fire or flame.

    When using this product • Keep out of eyes, ears, or mouth. • In case of eye contact, flush eyes thoroughly with water. • Avoid contact with broken skin. • Do not inhale or ingest.

    Stop use and ask a doctor if • redness or irritation develop

    • condition persists for more than 72 hours

    Keep out of reach of children.

    • Children should be supervised by an adult when using this product. • If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Wet hand thoroughly with product and allow to dry without wiping. • No rinsing required. • For children under 6, use only under adult supervision. • Not recommended for infants.

  • Other information

    • Store below 105˚F(40˚C). • May discolor certain fabrics. • Harmful to wood finishes & plastics

  • Inactive ingredients:

    Water(Aqua), Triethanolamine, Carbomer, Aloe Barbadensis(Aloe Vera) Gel, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate(Vitamin E).

  • SPL UNCLASSIFIED SECTION

    UPC CODE

    Distributed by:

    Natural Dyes Inc.

    New York, NY 10018

    Made in China

    Kills 99.9% of Germs

    Moisturizing Formula

    70% Alcohol 

    Sanitary

    Aloe

    E

    Vitamin E

  • Packaging

    IMAGE

  • INGREDIENTS AND APPEARANCE
    ZAPIRE HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77781-002
    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)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77781-002-02237 mL in 1 BOTTLE; Type 0: Not a Combination Product05/30/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A05/30/2020
    Labeler - Natural Dyes Inc (078772235)
    Establishment
    NameAddressID/FEIBusiness Operations
    PUJIANG SHIJIALI COSMETICS CO., LTD.529748603manufacture(77781-002)
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