Label: SANITAXE- hand sanitizer liquid

  • 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 July 31, 2014

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  • SPL UNCLASSIFIED SECTION

    DRUG FACTS

  • ACTIVE INGREDIENTS

    ETHYL ALCOHOL 62%

  • PURPOSE

    Antiseptic

  • 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 and 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.

  • Directions

    pump as needed into your palms and thoroughly spread on both hands. rub into skin until dry.

  • Inactive ingredients

    water, triethanolamine, glycerin, propylene glycol, tocopheryl acetate, aloe barbadensis gel, carbomer, fragrance

  • PRINCIPAL DISPLAY PANEL

    Package Label

  • INGREDIENTS AND APPEARANCE
    SANITAXE 
    hand sanitizer liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76176-003
    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) 50 mL  in 100 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76176-003-08800 mL in 1 BOX
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A07/31/2014
    Labeler - NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD (530766098)
    Establishment
    NameAddressID/FEIBusiness Operations
    NINGBO LIYUAN DAILY CHEMICAL PRODUCTS CO LTD530766098manufacture(76176-003)
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