Label: CHLORHEXIDINE GLUCONATE solution

  • NDC Code(s): 51072-047-01
  • Packager: Aurora Pharmaceutical, Inc.
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated November 29, 2021

If you are a consumer or patient please visit this version.

  • INDICATIONS

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

  • ACTIVE INGREDIENT

    4% chlorhexidine gluconate

  • 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.

  • 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.

    Do not use if allergic or sensitive to the active ingredients.

    For veterinary use only.

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF REACH OF CHILDREN.

  • STORAGE

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

  • OTHER INGREDIENTS

    Fragrance, isopropyl alcohol, water, dye, aloe vera and other ingredients in a nonalkaline base.

  • SPL UNCLASSIFIED SECTION

    image description

    MANUFACTURED IN THE USA

    REORDER NO: 59003

    MANUFACTURED BY:
    Aurora Pharmaceutical, Inc.
    NORTHFIELD, MINNESOTA 55057
    1-888-215-1256
    www.aurorapharmaceutical.com

    IN 50-1149  02/2021

  • PRINCIPAL DISPLAY PANEL - 1 Gallon 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 Animal Use Only

    1 Gallon (3.79 L)

    AURORA PHARMACEUTICAL ®

    PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:51072-047
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE40 g  in 1 L
    Product Characteristics
    ColorgreenScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51072-047-014 in 1 CARTON
    13.79 L in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/31/2012
    Labeler - Aurora Pharmaceutical, Inc. (832848639)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurora Pharmaceutical, Inc.832848639manufacture