Label: CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution 

  • NDC Code(s): 51072-045-01
  • Packager: Aurora Pharmaceutical LLC
  • 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 08/14

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  • INDICATIONS

    An antiseptic and antimicrobial disinfectant which provides fast-acting activity against a wide range of microorganisms, especially against those commonly found on the skin. A 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

    Chlorhexidine Gluconate 2% w/v

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  • DILUTION

    Add 1 ounce (2 tablespoons) of Chlorhexidine Gluconate solution per gallon of clean water.

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  • DIRECTIONS FOR USE

    Rinse area to be disinfected with an ample amount of the Chlorhexidine Gluconate solution. Wipe away excess and pat dry with a sterile gauze or sponge.

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  • WARNING

    In case of accidental ingestion, seek professional assistance or contact a Poison Control Center immediately.

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  • 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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  • STORAGE AND HANDLING

    Store at controlled room temperature between 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Do not freeze.

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  • SPL UNCLASSIFIED SECTION

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    REORDER NO: 31007

    MANUFACTURED BY:

    Aurora Pharmaceutical, LLC
    NORTHFIELD, MN 55057
    888-215-1256
    www.aurorapharmaceutical.com
    IN 50-1129 03/2013

    MANUFACTURED IN THE USA

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  • PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

    PRO-TEC™

    Chlorhexidine Gluconate

    2% w/v Solution

    Antiseptic - Disinfectant

    For External Animal Use Only

    1 Gallon (3.79 L)

    AURORA PHARMACEUTICAL®

    Principal Display Panel - 1 Gallon Bottle Label

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  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:51072-045
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE 20 g  in 1 L
    Product Characteristics
    Color blue Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51072-045-01 4 in 1 CARTON
    1 3.79 L in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 12/02/2011
    Labeler - Aurora Pharmaceutical LLC (832848639)
    Establishment
    Name Address ID/FEI Business Operations
    Aurora Pharmaceutical LLC 832848639 MANUFACTURE
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