Label: ASSURED HAND SANITIZER WITH VITAMIN E- ethyl 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, 2012

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 70% v/v

  • PURPOSE

    Purpose
    Antiseptic

  • INDICATIONS & USAGE

    Uses • hand sanitizer to help reduce bacteria on the skin •recommended for repeated use.

  • WARNINGS

    Warnings •Flammable. • Keep away from fire and flame. •For external use only

  • WHEN USING

    When using this product •avoid contact with eyes • in case of eye contact immediately flush eyes with water, call a doctor • avoid contact with broken skin.
    Discontinue use if irritation develops. If condition persists for more than 72 hours, consult a doctor.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. Children should only use this product under adult supervision. Do not drink. Not edible. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

  • SPL UNCLASSIFIED SECTION

    Other information • do not store above 105F. May discolor some fabrics. • Harmful to wood finishes and plastics

  • DOSAGE & ADMINISTRATION

    Directions • place enough product in your palm to thoroughly spread on both hands and rub into the skin until dry. • recommended for repeated use

  • INACTIVE INGREDIENT

    Inactive ingredients carbomer, fragrance, glycerin, isopropyl alcohol, PEG-40 hydrogenated castor oil, propylene glycol, triethanolamine, tocopheryl acetate, water

  • PRINCIPAL DISPLAY PANEL

    image description

  • INGREDIENTS AND APPEARANCE
    ASSURED  HAND SANITIZER WITH VITAMIN E
    ethyl alcohol liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:33992-4947
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    ISOPROPYL ALCOHOL (UNII: ND2M416302)  
    POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    ALPHA-TOCOPHEROL (UNII: H4N855PNZ1)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:33992-4947-8236 mL in 1 BOTTLE, PUMP
    2NDC:33992-4947-1295 mL in 1 BOTTLE, PUMP
    3NDC:33992-4947-2355 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A10/01/2012
    Labeler - Greenbrier International Inc. (610322518)
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