Label: CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution 

  • NDC Code(s): 51072-047-01
  • 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 02/13

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  • INDICATIONS

    PRO-TEC™ ChlorSeptic 4% is a mild scrub containing chlorhexidine gluconate 4% that exhibits bactericidal activity against a wide range of microorganisms.

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  • ACTIVE INGREDIENT

    4% chlorhexidine gluconate.

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  • OTHER INGREDIENTS

    Purified water, lauramine oxide, isopropyl alcohol, polyethylene glycol, propanediol, hydroxyethylcellulose, aloe vera, fragrance and dye.

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  • DIRECTIONS FOR USE

    Wet area thoroughly with water. Pour approximately 5 mL of ChlorSeptic 4% and add enough water to make a lather. Lather thoroughly. Rinse thoroughly with clean water.

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  • WARNINGS

    Avoid contact with eyes and mucous membranes. If in eyes, immediately flush with water for 15 minutes and contact a physician. If swallowed, contact a physician and/or poison control center immediately.

    For veterinary use only.

    KEEP OUT OF REACH OF CHILDREN.

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  • STORAGE

    Store at 20°– 25° C (68°– 77° F). Excursions permitted between 15°– 30° C (59°– 86° F). Keep container tightly closed when not in use.

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  • SPL UNCLASSIFIED SECTION

    Take Time

    REORDER NO: 59003

    MANUFACTURED BY:
    Aurora Pharmaceutical, LLC
    NORTHFIELD, MINNESOTA 55057
    888-215-1256
    www.aurorapharmaceutical.com

    IN 50-1149 REV 01

    MANUFACTURED
    IN THE USA

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  • PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

    NDC 51072-047-01

    PRO-TEC

    CHLORSEPTIC
    4%
    with Aloe Vera

    Antiseptic Antimicrobial
    Skin Cleanser

    Fast-acting, broad-spectrum
    antimicrobial skin cleanser

    For External Use Only

    1 Gallon (3.79 L)

    aurora
    PHARMACEUTICAL®

    PRINCIPAL DISPLAY PANEL - 3.79 L 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:51072-047
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Chlorhexidine Gluconate (Chlorhexidine) Chlorhexidine Gluconate 40 g  in 1 L
    Inactive Ingredients
    Ingredient Name Strength
    Water 786 g  in 1 L
    ISOPROPYL ALCOHOL  
    HYDROXYETHYL CELLULOSE (5000 MPA.S AT 1%)  
    POLYETHYLENE GLYCOL 8000  
    LAURAMINE OXIDE  
    ACEMANNAN  
    PROPANEDIOL  
    FD&C GREEN NO. 3  
    FD&C YELLOW NO. 5  
    Product Characteristics
    Color GREEN Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51072-047-01 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 05/31/2012
    Labeler - Aurora Pharmaceutical LLC (832848639)
    Establishment
    Name Address ID/FEI Business Operations
    Aurora Pharmaceutical LLC 832848639 MANUFACTURE
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