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Hibiclens: Package Insert / Prescribing Info

Package insert / product label
Generic name: (chlorhexidine gluconate
Dosage form: topical solution
Drug classes: Antiseptic and germicides, Mouth and throat products

Medically reviewed by Drugs.com. Last updated on Nov 11, 2024.

Active Ingredient

Chlorhexidine gluconate solution 4.0% w/v

Purpose

Antiseptic

Indications and Usage for Hibiclens

  • 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

For external use only

Allergy alert

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

  • 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

  • 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

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

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

Hibiclens 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 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

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

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

Questions?

1-800-843-8497

Laundering and Cleaning 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)

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)

Hibiclens 4oz Bottle label

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)

Hibiclens 1 gallon bottle label

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)

Hibiclens 32oz bottle label

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)

Hibiclens 16oa bottle label

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)

Hibiclens 8oz Fm bottle label

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)

Hibiclens 8oz Bottle label

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)

Hibiclens 4oz FM

Hibiclens 16oz Shelf Carton labelHibiclens 8oz Shelf Carton labelHibiclens 8oz fm Shelf Carton labelHibiclens 4oz Shelf Carton label

HIBICLENS
chlorhexidine gluconate 4% solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0116-0575
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE213 g in 1000 mL
Inactive Ingredients
Ingredient NameStrength
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
POLOXAMER 237 (UNII: JT3U72U71K)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0116-0575-41118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2024
2NDC:0116-0575-913790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2024
3NDC:0116-0575-04118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2024
4NDC:0116-0575-08236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2024
5NDC:0116-0575-80236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2024
6NDC:0116-0575-16473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2024
7NDC:0116-0575-32946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product01/30/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA01776801/30/2024
Labeler - Xttrium Laboratories, Inc. (007470579)
Registrant - Xttrium Laboratories, Inc. (007470579)
Establishment
NameAddressID/FEIBusiness Operations
Xttrium Laboratories, Inc.007470579manufacture(0116-0575)