Label: CHLORHEXIDINE SOLUTION 2%- chlorhexidine gluconate solution, concentrate

  • NDC Code(s): 66818-009-01
  • Packager: American Animal Health, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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 08/09

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  • Product Description

    PRODUCT DESCRIPTION:

    An antiseptic and antimicrobial

    disinfectant which provides fast

    acting activity against a wide range

    of microorganisms, especially

    against those commonly present

    on the skin.

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  • Directions for Use

    DIRECTIONS FOR USE:

    DILUTION:

    One ounce (2 tablespoons) of

    Chlorhexidine Solution per gallon

    of water.

    Rinse area to be disinfected with

    an ample amount of diluted

    Chlorhexidine Solution. Wipe

    away excess and pat dry with a

    sterile gauze or sponge.

    Non-toxic, non-irritating agent

    possessing a wide range of

    antiseptic and antimicrobial activity

    against organisms which infect the

    skin, such as bacteria, fungi,

    ringworm and yeast.

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  • Active ingredient

    ACTIVE INGREDIENT:

    Chlorhexidine gluconate 2%

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  • Caution

    CAUTION:

    For external use only. Avoid contact

    with eyes, ears, and mucous

    membranes. If contact occurs,

    immediately flush with water.

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  • Keep out of Reach of Children

    Keep out of Reach of Children

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  • Warning

    WARNING:

    In case of accidental ingestion, seek

    professional assistance or contact the

    poison control center immediately.

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  • Principal Display Panel

    AAH

    Chlorhexidine

    Solution

    Chlorhexidine Gluconate 2.0%

    For Animal Use Only

    NET WT.3.78 L (128 fl oz) (1 gal)

    Distributed by:

    American Animal Health, Inc.

    1401 Joel East road - Fort Worth, TX 76140

    1800-272-8338

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  • Bottle Label Image

    Bottle Label Image


    Bottle label Image




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  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE SOLUTION  2%
    chlorhexidine gluconate solution, concentrate
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:66818-009
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlorhexidine gluconate (Chlorhexidine) Chlorhexidine gluconate 83.16 mL  in 3780 mL
    Inactive Ingredients
    Ingredient Name Strength
    Nonoxynol 9  
    Water  
    Product Characteristics
    Color blue (FD&C Blue No.1) Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:66818-009-01 3780 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved other 06/26/2008
    Labeler - American Animal Health, Inc. (102617875)
    Registrant - American Animal Health, Inc. (102617875)
    Establishment
    Name Address ID/FEI Business Operations
    American Pharmaceuticals and Cosmetics, Inc. 038023805 manufacture, analysis
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