Label: HAND SANITIZER- alcohol liquid

  • 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 September 8, 2010

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  • ACTIVE INGREDIENT

    Active Ingredient:      Ethyl Alcohol   62%
  • PURPOSE

    Purpose:  Antiseptic
  • INDICATIONS & USAGE

    Uses:    To decrease bacteria on the skin that could cause disease


  • WARNINGS


    Warnings: For external use only-hands. Flammable. Keep away from heat and flame.

    When using this 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

    Stop use and see a doctor if skin irritation develops.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or call a poison control center right away

  • INACTIVE INGREDIENT

    Carbomer, Fragrance, Glycerin, Propylene Glycol, Tocopheryl Acetate, Triethanolamine, Water
  • STORAGE AND HANDLING

    Other Information

    Do not store above 105F

    May discolor some fabric

    Harmful to wood finishes and plastics

  • DOSAGE & ADMINISTRATION


    Directions: Wet hands thoroughly with products and allow to dry without wiping. For children under 6 use only under adult supervision. Not recommended for infants
  • PRINCIPAL DISPLAY PANEL

    labelabel

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52174-002
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL62 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 36.43 g  in 100 g
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) 0.02 g  in 100 g
    CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E) 0.2 g  in 100 g
    TROLAMINE (UNII: 9O3K93S3TK) 0.2 g  in 100 g
    GLYCERIN (UNII: PDC6A3C0OX) 0.5 g  in 100 g
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3) 0.5 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52174-002-0110 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E09/08/2010
    Labeler - Ningbo Kleen Products Co., Ltd. (529352816)
    Registrant - Ningbo Kleen Products Co., Ltd. (529352816)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ningbo Kleen Products Co., Ltd.529352816manufacture