Label: HAND SANITIZER ANTICEPTIC- alcohol gel

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

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 December 21, 2018

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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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