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.
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- 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
- 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.
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
- 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.
- 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
- SPL UNCLASSIFIED SECTION
REORDER NO: 59004
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
IN 50-1155 REV 01
MANUFACTURED IN THE USAClose
- PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label
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 ®
- INGREDIENTS AND APPEARANCE
chlorhexidine gluconate solution
Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:51072-048 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 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)