Hibiclens by A-S Medication Solutions Hibiclens, 4% CHG

Drug Details [pdf]

HIBICLENS- chlorhexidine gluconate solution
A-S Medication Solutions

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Hibiclens, 4% CHG

Chlorhexidine gluconate solution 4.0% w/v

Antiseptic

Uses

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

For external use only

Allergy alert:

This product may cause 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 a 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 5mL of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
healthcare personnel handwash. Wet hand with water. Dispense about 5mL 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

Chlorhexidine gluconate

HIBICLENS
chlorhexidine gluconate solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 50090-2354(NDC: 0234-0575)
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	213 g in 1000 mL

Ingredient Name	Strength
Inactive Ingredients
POLOXAMER 237 (UNII: JT3U72U71K)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
FD&C RED NO. 40 (UNII: WZB9127XOA)

Product Characteristics
Color	red	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC: 50090-2354-0	1 in 1 CARTON	04/18/2016	05/31/2019
1		118 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
NDA	NDA017768	09/17/1976	05/31/2019

Labeler - A-S Medication Solutions (830016429)

Name	Address	ID/FEI	Business Operations
Establishment
A-S Medication Solutions		830016429	RELABEL(50090-2354)

Revised: 1/2020

Document Id: 67bf3db9-7bd4-43d4-9a09-15fe7b7937a6

Set id: ae865379-f2d9-4b95-bdb4-42438a7c9b54

Version: 7

Effective Time: 20200118

A-S Medication Solutions