FDA Label for Hibiclens
View Indications, Usage & Precautions
Hibiclens Product Label
The following document was submitted to the FDA by the labeler of this product Physicians Total Care, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Otc - Purpose
| 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.
Otc - Keep Out Of Reach Of Children
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
* Please review the disclaimer below.