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Hibiclens by Physicians Total Care, Inc.

Dosage form: solution
Ingredients: CHLORHEXIDINE GLUCONATE 213g in 1000mL
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-3046

HIBICLENS®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Drug Facts

Active ingredientPurpose
Chlorhexidine gluconate
solution 4.0% w/v
Antiseptic

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

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 in any of these areas, rinse with cold water right away

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.

Keep out of reach of children.

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

Directions
  • skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of HIBICLENS 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 5mL of HIBICLENS with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
  • personnel hand wash. Wet hands with water. Dispense about 5mL of HIBICLENS into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
  • preoperative skin preparation. Apply HIBICLENS 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).

Inactive ingredients

fragrance, isopropyl alcohol 4% w/v, purified water, Red 40, and other ingredients in a nonalkaline base.

Questions?

1-800-843-8497

PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

NDC 54868-3046-1

HIBICLENS®
(Chlorhexidine Gluconate
solution 4.0% w/v)

Antiseptic/Antimicrobial Skin Cleanser

HIBICLENS® prevents skin infections thereby reducing the risk of cross-
infection. HIBICLENS® has antiseptic activity and a persistent antimicrobial
effect with rapid bactericidal activity against a wide range of microorganisms.

MÖLNLYCKE®
HEALTH CARE

8 Fl. oz. (236 mL)

Distributed by Mölnlycke Health Care US, LLC
Norcross, GA 30092



Additional barcode labeling by:
Physicians Total Care, Inc.
Tulsa, Oklahoma       74146
HIBICLENS 
chlorhexidine gluconate solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-3046(NDC:0234-0575)
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (CHLORHEXIDINE) CHLORHEXIDINE GLUCONATE213 g  in 1000 mL
Inactive Ingredients
Ingredient NameStrength
Isopropyl alcohol 
FD&C Red NO. 40 
Water 
Product Characteristics
ColorREDScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-3046-01 BOTTLE (BOTTLE) in 1 CARTON
1118 mL in 1 BOTTLE
2NDC:54868-3046-11 BOTTLE (BOTTLE) in 1 CARTON
2236 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01776811/17/2004
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIOperations
Physicians Total Care, Inc.194123980relabel(54868-3046)

Revised: 09/2012
 
Physicians Total Care, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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