FDA.reportPublic FDA data

Hibiclens

Manufacturer
Xttrium Laboratories, Inc.
Effective date
2025-04-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:38:58

Label at a glance#

ProductHibiclens
Active ingredientCHLORHEXIDINE GLUCONATE
Label structure13 sections

Indications and uses

antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease for skin wound and general skin cleansing surgical hand scrub healthcare personnel handwash

Dosage and administration

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns. skin wound and general skin cleansing. Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product 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 abo...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Chlorhexidine gluconate solution 4.0% w/v

Purpose

OTC - PURPOSE SECTION

Antiseptic

Uses

INDICATIONS & USAGE SECTION

  • antimicrobial skin cleanser helps reduce bacteria that potentially can cause disease
  • for skin wound and general skin cleansing
  • surgical hand scrub
  • healthcare personnel handwash

Warnings

WARNINGS SECTION

For external use only

Allergy alert

OTHER SAFETY INFORMATION

This product may cuase a severe allergic reaction. Symptoms may include:

  • wheezing/difficulty breathing
  • shock
  • facial swelling
  • hives
  • rash

If an allergic reaction occurs, stop use and seek medical help right away.

Do not use

OTC - DO NOT USE SECTION

  • if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
  • in contact with the meninges
  • in the genital area

When using this product

OTC - WHEN USING SECTION

  • keep out of eyes, ears, and mouth. May cause serious and permanent eye injury if permitted to enter and remain in the eye 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
  • wounds which involve more than the superficial layers of the skin should not be routinely treated
  • repeated general cleansing of large body areas should not be done except when advised by a health care provider

Stop use and ask doctor if

OTC - ASK DOCTOR SECTION

irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.
  • skin wound and general skin cleansing.

Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product 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 5 mL (4 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.

  • healthcare personnel handwash.

Wet hands with water. Dispense about 5 mL (4 pumps) of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.

Other information

OTHER SAFETY INFORMATION

  • store between 20-25°C (68-77°F)
  • avoid excessive heat above 40°C (104°F)

INACTIVE INGREDIENT SECTION

fragrance, gluconolactone, isopropyl alcohol 4% w/v, lauramine oxide, poloxamer 237, purified water and red 40

Questions?

OTC - QUESTIONS SECTION

1-800-843-8497

Laundering and Cleaning Instructions

CLEANING, DISINFECTING, AND STERILIZATION INSTRUCTIONS

Chlorhexidine gluconate skin cleansers wil cause stains in used with chlorine releasing products. Rinse completely and use only non-chlorine detergents

Principal Display Panel (Labels)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0234-0575-04

Hibiclens

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic Skin Cleanser

Persistent Effect

Great for Hand Hygiene

General Skin Cleansing

Helps reduce bacteria that potentially can cause disease

4oz (118mL)

NDC 0234-0575-91

Hibiclens

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic Skin Cleanser

Persistent Effect

Great for Hand Hygiene

General Skin Cleansing

Helps reduce bacteria that potentially can cause disease

1 gal (3.79L)

NDC 0234-0575-32

Hibiclens

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic Skin Cleanser

Persistent Effect

Great for Hand Hygiene

General Skin Cleansing

Helps reduce bacteria that potentially can cause disease

32oz (946mL)

NDC 0234-0575-16

Hibiclens

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic Skin Cleanser

Persistent Effect

Great for Hand Hygiene

General Skin Cleansing

Helps reduce bacteria that potentially can cause disease

16oz (473 mL)

NDC 0234-0575-80

Hibiclens

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic Skin Cleanser

Persistent Effect

Great for Hand Hygiene

General Skin Cleansing

Helps reduce bacteria that potentially can cause disease

with foam pump Replace cap after use

8oz (236mL)

NDC 0234-0575-08

HIbiclens

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic Skin Cleanser

Persistent Effect

Great for Hand Hygiene

General Skin Cleansing

Helps reduce bacteria that potentially can cause disease

8oz (236mL)

NDC 0234-0575-41

Hibiclens

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic Skin Cleanser

Persistent Effect

Great for Hand Hygiene

General Skin Cleansing

Helps reduce bacteria that potentially can cause disease

with foam pump Replace cap after use

4fl oz (118mL)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hibiclens LabelHibiclens Label

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0116-0575HIBICLENS (CHLORHEXIDINE GLUCONATE 4%) SOLUTION [XTTRIUM LABORATORIES, INC.]3Unmatched20250519_102afe55-eb58-971b-e063-6394a90ae9b0.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0116-05750116-0575-41, 0116-0575-91, 0116-0575-04, 0116-0575-08, 0116-0575-80, 0116-0575-16, 0116-0575-32

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
CHLORHEXIDINE GLUCONATEMOR84MUD8EACTIB
LAURAMINE OXIDE4F6FC4MI8WIACT
WATER059QF0KO0RIACT
FD&C RED NO. 40WZB9127XOAIACT
GLUCONOLACTONEWQ29KQ9POTIACT
ISOPROPYL ALCOHOLND2M416302IACT
POLOXAMER 237JT3U72U71KIACT

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
33ebd52e-91db-0988-e063-6394a90a0941102afe55-eb58-971b-e063-6394a90ae9b02025-04-29WarningsExact identifier
spl id: 33ebd52e-91db-0988-e063-6394a90a0941
spl set id: 102afe55-eb58-971b-e063-6394a90ae9b0

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.