Label: HAND SANITIZER- 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 July 15, 2022

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  • ACTIVE INGREDIENT

    Alcohol 70% w/w......................Antiseptic

  • PURPOSE

    Antiseptic Cleanser, helps decrease bacteria on skin.

  • 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.

  • INDICATIONS & USAGE

    Antiseptic Cleanser, helps decrease bacteria on skin

    Children under 6 years of ageshould be supervised when usingthis product.

  • WARNINGS

    Warnings For external use only. Flammable. Keep product away from fire or flame.

  • DOSAGE & ADMINISTRATION

    Place enough product onyour palm to thoroughly coveryour hands.
    Rub hands together brisklyuntil dry.

  • STORAGE AND HANDLING

    Store below 110°F (43°C).May discolor certain fabricsor surfaces.

  • INACTIVE INGREDIENT

    Aqua/Water/Eau, Glycerin, Carbomer, Triethanolamine, Fragrance(Parfum).

  • PRINCIPAL DISPLAY PANEL

    lab

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82874-002
    Route of AdministrationCUTANEOUS
    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)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82874-002-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product07/14/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/14/2022
    Labeler - Xiamen Tiross Biological Technology Co.,Ltd (724185760)
    Establishment
    NameAddressID/FEIBusiness Operations
    Xiamen Tiross Biological Technology Co.,Ltd724185760manufacture(82874-002)
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