HIBICLENS- chlorhexidine gluconate 4% solution

Hibiclens by

Drug Labeling and Warnings

Hibiclens by is a Otc medication manufactured, distributed, or labeled by Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Chlorhexidine gluconate solution 4.0% w/v

Purpose

Antiseptic

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

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.

KEEP OUT OF REACH OF CHILDREN

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

Directions

• 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)

INACTIVE INGREDIENT

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)

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)

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

HIBICLENS 
chlorhexidine gluconate 4% solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 0116-0575
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0116-0575-41	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2024
2	NDC: 0116-0575-91	3790 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2024
3	NDC: 0116-0575-04	118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2024
4	NDC: 0116-0575-08	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2024
5	NDC: 0116-0575-80	236 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2024
6	NDC: 0116-0575-16	473 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2024
7	NDC: 0116-0575-32	946 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	01/30/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA017768	01/30/2024

Labeler - Xttrium Laboratories, Inc. (007470579)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(0116-0575)