Label: HIBICLENS- chlorhexidine gluconate solution
Contains inactivated NDC Code(s)
NDC Code(s): 54868-3046-0, 54868-3046-1
- Packager: Physicians Total Care, Inc.
- This is a repackaged label.
- Source NDC Code(s): 0234-0575
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated September 19, 2012
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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.
- 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
- Inactive ingredients
PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
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.
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
INGREDIENTS AND APPEARANCE
chlorhexidine gluconate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-3046(NDC:0234-0575) Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 213 g in 1000 mL Inactive Ingredients Ingredient Name Strength 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 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 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 Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017768 11/17/2004 Labeler - Physicians Total Care, Inc. (194123980) Establishment Name Address ID/FEI Business Operations Physicians Total Care, Inc. 194123980 relabel(54868-3046)