HAND SANITIZER ANTICEPTIC (ALCOHOL) GEL [AZTEX ENTERPRISES]

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HAND SANITIZER ANTICEPTIC (ALCOHOL) GEL [AZTEX ENTERPRISES]
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NDC 75887-001-01, 75887-001-02, 75887-001-03, 75887-001-04, 75887-001-05
Set ID 46a655c9-0391-46c8-af77-d0a11bac9557
Category HUMAN OTC DRUG LABEL
Packager Aztex Enterprises
Generic Name
Product Class
Product Number
Application Number PART333A
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  • PURPOSE

    Uses

    for handwashing to decrease bacteria on the skin.

  • WARNINGS

    Warnings for external use only.

    When using this product; Do not use in eyes.

    Discontinue use if irritation and redness develop

  • INDICATIONS & USAGE

    Directions

    wet hand thoroughly with product

    briskly rub hands together until dry

  • INACTIVE INGREDIENT

    Inactive Ingredients

    Deionized water

    Glycerin

    Propylen Glycol

    Triethanolamine

    Carbomer

    Methyloaraben

    Proplyparaben

    Lemon Fragrance

  • ACTIVE INGREDIENT

    Drug Fact 8ml/0.25 fl.oz. Made in Canada -> (L) 8295

    Active ingredient Purpose

    Ethyl alcohol 62% Antisepctic

  • DOSAGE & ADMINISTRATION

    8ml/0.25 fl. oz.

  • KEEP OUT OF REACH OF CHILDREN

    Flammable, keep away from fire or flames.

    Keep out of reach of children

    If swallowed contact a Poison Control Center right away

    If pregnant or breast feeding, ask a health care professional before use

  • PRINCIPAL DISPLAY PANEL

    Label Image Anticeptic Hand Sanitizer

    AZX SPORT

    Manufactured for

    AZX SPORT

    925 Century Drive

    Burlington, ON L7L 5LB

  • INGREDIENTS AND APPEARANCE
    HAND SANITIZER  ANTICEPTIC
    alcohol gel
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:75887-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ALCOHOL (UNII: 3K9958V90M) (ALCOHOL - UNII:3K9958V90M) ALCOHOL5 mL  in 8 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER 1342 (UNII: 809Y72KV36)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorLEMON (Lemon Fragrance) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:75887-001-0130 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
    2NDC:75887-001-0260 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
    3NDC:75887-001-038 mL in 1 BOTTLE, SPRAY; Type 0: Not a Combination Product01/13/2011
    4NDC:75887-001-04118 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
    5NDC:75887-001-05236 mL in 1 BOTTLE; Type 0: Not a Combination Product01/13/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart333A01/13/2011
    Labeler - Aztex Enterprises (253232326)
    Registrant - Aztex Enterprises (253232326)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aztex Enterprises253232326manufacture(75887-001)
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