Drug Facts

Active ingredient	Purpose
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

Principal Display Panel - 236 mL Bottle Label

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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54868-3046(NDC:0234-0575)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	213 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
Isopropyl alcohol (UNII: ND2M416302)
FD&C Red NO. 40 (UNII: WZB9127XOA)
Water (UNII: 059QF0KO0R)

Product Characteristics
Color	RED	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description
Packaging
1	NDC:54868-3046-0	1 in 1 CARTON
1		118 mL in 1 BOTTLE
2	NDC:54868-3046-1	1 in 1 CARTON
2		236 mL in 1 BOTTLE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA017768	11/17/2004

Labeler - Physicians Total Care, Inc. (194123980)

Name	Address	ID/FEI	Business Operations
Establishment
Physicians Total Care, Inc.		194123980	relabel(54868-3046)

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