Label: CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution

  • NDC Code(s): 51072-048-01
  • 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 10/14

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

  • VETERINARY INDICATIONS

    ChlorSeptic continues to kill germs up to 6 hours after washing, is gentle to skin, and prevents skin infections, thereby reducing the risk of cross-infection.

    Close
  • DRUG FACTS

     ACTIVE INGREDIENT  PURPOSE
     Chlorhexidine Gluconate 2% w/v Antiseptic 

    Close
  • USES

    • Antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease.
    • For skin wound and general skin cleansing.
    • Surgical hand scrub.
    • Personnel hand wash.
    • Preoperative skin preparation.
    Close
  • WARNINGS

    For external use only

    Do not use

    • if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation.
    • as a patient preoperative skin preparation of the head or face.
    • in contact with the meninges.
    • in the genital area.
    • on wounds that involve more than the superficial layers of skin.

    When using this product

    • keep out of eyes, ears and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures, or may cause deafness when instilled in the middle ear through perforated eardrums.
    • if contact occurs, immediately flush and thoroughly clean with cold water.

    Stop use and ask a doctor if irritation, sensitization or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.

    Close
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children.

    If swallowed, get medicinal help or contact a Poison Control Center right away.

    Close
  • Directions

    • Skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of ChlorSeptic necessary to cover the skin or wound area and wash gently. Rinse thoroughly.
    • Surgical hand scrub. Wet hands and forearms with water. Scrub for 3 minutes with about 5 ml of ChlorSeptic with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
    • Personnel hand wash. Wet hands with water. Dispense about 5 ml of ChlorSeptic into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
    • Preoperative skin preparation. Apply ChlorSeptic liberally to surgical site and swab for at least 2 minutes. Dry with a sterile towel. Repeat. Dry with a sterile towel.
    Close
  • Other information

    Store between 20°–25° C (68°–77° F).

    Close
  • Inactive Ingredients

    Fragrance, isopropyl alcohol 4% w/v, purified water, Blue-1, Yellow-5, aloe vera, and other ingredients in a nonalkaline base.

    Close
  • Questions?

    1-888-215-1256

    Close
  • SPL UNCLASSIFIED SECTION

    REORDER NO: 59004

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

    IN 50-1155 REV 01

    MANUFACTURED IN THE USA

    Close
  • PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

    NDC 51072-048-01

    PRO-TECTM

    ChlorSeptic

    2%

    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 - 1 Gallon Bottle Label

    Close
  • INGREDIENTS AND APPEARANCE
    CHLORHEXIDINE GLUCONATE 
    chlorhexidine gluconate solution
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:51072-048
    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 green Score     
    Shape Size
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51072-048-01 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)
    Close