Hibiclens
FDA Label NDC 54868-3046

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Physicians Total Care, Inc. for the product Hibiclens (NDC 54868-3046). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding otc - purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

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.

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

Principal Display Panel (236 mL Bottle Label)

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

* Please review the disclaimer below.