FOAMING HAND WASH- chlorhexidine gluconate liquid

foaming hand wash by

Drug Labeling and Warnings

foaming hand wash by is a Otc medication manufactured, distributed, or labeled by Medline Industries, LP. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Chlorhexidine gluconate 2% solution

Purpose

Antiseptic

Use

• Surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
• Healthcare personnel handwash: helps reduce bacteria that potentially can cause disease

Warning

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 are allergic to chlorhexidine gluconate or any other ingredient in this product

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 solution should contact these areas, rinse out promptly and thoroughly with water
• do not use routinely if you have wounds which involve more than the superficial layers of the skin

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.

Surgical hand scrub:

• wet hands and forearms with water
• scrub for 3 minutes with 5 mL of product (7 strokes) and a wet brush, paying close attention to the nails, cuticles and skin between the fingers
• a separate nail cleaner may be used
• rinse thoroughly
• wash for an additional 3 minutes with 5 mL of product (7 strokes) and rinse under running water and dry thoroughly

Healthcare personnel handwash:

• wet hands with water
• dispense 5 mL of product (7 strokes) into cupped hands and wash in a vigorous manner for 15 seconds
• rinse and dry thoroughly

Other information

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

Inactive ingredients

citric acid, cocamide DEA, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, purified water

Package Label

INGREDIENTS AND APPEARANCE

FOAMING HAND WASH 
chlorhexidine gluconate liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 53329-994
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	20 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
COCO DIETHANOLAMIDE (UNII: 92005F972D)
LAURAMINE OXIDE (UNII: 4F6FC4MI8W)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 53329-994-84	1000 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/01/2020

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019422	01/01/2020

Labeler - Medline Industries, Inc. (025460908)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(53329-994)