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

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 Item Code (Source) NDC:51072-045
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) 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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