Label: ASSURED HAND SANITIZER WITH VITAMIN E- alcohol liquid

  • NDC Code(s): 33992-4947-1, 33992-4947-2, 33992-4947-8
  • Packager: Greenbrier International Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/12

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  • ACTIVE INGREDIENT

    Active Ingredient

    Ethyl Alcohol 70% v/v

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  • PURPOSE

    Purpose
    Antiseptic

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  • INDICATIONS & USAGE

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

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  • WARNINGS

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

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  • 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.

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  • 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.

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  • SPL UNCLASSIFIED SECTION

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

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  • 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

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  • INACTIVE INGREDIENT

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

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  • INGREDIENTS AND APPEARANCE
    ASSURED  HAND SANITIZER WITH VITAMIN E
    ethyl alcohol liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:33992-4947
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    ALCOHOL (ALCOHOL) ALCOHOL 70 mL  in 100 mL
    Inactive Ingredients
    Ingredient Name Strength
    GLYCERIN  
    ISOPROPYL ALCOHOL  
    POLYOXYL 40 HYDROGENATED CASTOR OIL  
    PROPYLENE GLYCOL  
    TROLAMINE  
    ALPHA-TOCOPHEROL  
    WATER  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-4947-8 236 mL in 1 BOTTLE, PUMP
    2 NDC:33992-4947-1 295 mL in 1 BOTTLE, PUMP
    3 NDC:33992-4947-2 355 mL in 1 BOTTLE, PUMP
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part333A 10/01/2012
    Labeler - Greenbrier International Inc. (610322518)
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