Label: ANTIBACTERIAL HAND SANITIZER GEL- 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 17, 2009

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  • ACTIVE INGREDIENT

    Active Ingredients                                             Purpose

    Ethyl Alcohol 62 percent                                   Antiseptic

  • PURPOSE

    Uses: Hand sanitizer to help decrease bacteria on the skin.

    When water, soap and towel are not available.

    Recommended for repeated use.

  • WARNINGS

    For external use only.

    Flammable. Keep away from fire or flame.

    Do not apply around eyes. Do not use in ears and mouth.

    When using this product, avoid contact with eyes.

    In case of contact flush eyes with water.

    Stop use and ask a doctor if redness or irritation develop and persist for more than 72 hours.

    Keep out of reach of children. Children must be supervised in use of this product.

  • DOSAGE & ADMINISTRATION

    Directions: Squirt as needed into your palms and thoroughly spread on both hands. Rub into skin until dry

  • STORAGE AND HANDLING

    Other Information: Store at 20 degrees C (68 degrees to 77 degrees F)

    May discolor fabrics

  • INACTIVE INGREDIENT


    Inactive Ingredients: water, triethanolamine, glycerin, propylene glycol, Vitamin E, aloe vera gel, carbormer, fragrance
  • PRINCIPAL DISPLAY PANEL

    Antibacterial Hand Sanitizer Gel

    2.0 Fl oz      60(ml)

    Made In China

  • PRINCIPAL DISPLAY PANEL

    HandSanitizer60ml

  • INGREDIENTS AND APPEARANCE
    ANTIBACTERIAL HAND SANITIZER GEL 
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49701-3000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49701-3000-160 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33312/01/2009
    Labeler - The Webb Company (785835294)
    Establishment
    NameAddressID/FEIBusiness Operations
    Cixi Zhixin Bird Clean-Care Product Co., Ltd. 529823986manufacture
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