HAND SANITIZER (ETHYL ALCOHOL) GEL [NPW-USA, INC.]

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HAND SANITIZER (ETHYL ALCOHOL) GEL [NPW-USA, INC.]
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NDC 49435-001-01
Set ID 290f5411-fda2-6521-e054-00144ff88e88
Category HUMAN OTC DRUG LABEL
Packager NPW-USA, Inc.
Generic Name
Product Class
Product Number
Application Number PART333E
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  • ACTIVE INGREDIENT

    Active ingredient:
    Ethyl alcohol, 62%

  • PURPOSE

    Purpose Antiseptic

  • WARNINGS

    Warnings:

    For external use only.

    FLAMMBLE. Keep away from fire or flame.

  • STOP USE

    Stop use and ask a doctor if irritation and redness persists for more than 72 hours.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. In case of accidental ingestion, seek medical attention or contact a Poison Control Center right away.

  • DOSAGE & ADMINISTRATION

    Directions:

    • Apply a small amount into palm of hand
    • Rub thoroughly over both hands until dry
    • Not to be rinsed off with water
    • Children must be supervised when using this product
    • For personal / domestic use
    • Do not dilute product
  • INACTIVE INGREDIENT

    Inactive ingredients: water, glycerin, propylene glycol, fragrance, carbomer, triethanolamine, acrylates copolymer, polyethylene terephthalate, red 33, diatomaceous earth.

  • STORAGE AND HANDLING

    Other Information:

    Do not store in temperatures above 118 F

  • INDICATIONS & USAGE

    Uses:

    • Hand sanitizer to help reduce bacteria on the skin.
    • Recommended for repeated use.
  • WHEN USING

    When using this product, avoid contact with eyes. In case of contact flush eyes with water.

  • PRINCIPAL DISPLAY PANEL

    image of bottle label

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER 
    ethyl alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49435-001
    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)  
    POLYETHYLENE TEREPHTHALATE (INTRINSIC VISCOSITY 0.70-1.00) (UNII: 645M2T7FHZ)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CARBOMER INTERPOLYMER TYPE A (55000 CPS) (UNII: 59TL3WG5CO)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    D&C RED NO. 33 (UNII: 9DBA0SBB0L)  
    METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (4500 MPA.S) (UNII: T967IEU43C)  
    DIATOMACEOUS EARTH (UNII: 2RF6EJ0M85)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:49435-001-0130 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/11/2016
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333E01/11/2016
    Labeler - NPW-USA, Inc. (079831598)
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