ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid

Antiseptic Skin Cleanser by

Drug Labeling and Warnings

Antiseptic Skin Cleanser by is a Otc medication manufactured, distributed, or labeled by Rite Aid, Xttrium Laboratories, Inc., Xttrium Laboratories, Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredient

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

• surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms proir to surgery or patient care
• healthcare personnel handwash: helkps reduce bacteria that potentially can cause disease
• skin wound and general skin cleansing

Warnings

For external use only

Allergy alert: This product may cause a severe allergic reaction. Symptoms may include:

• wheexing/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 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 eardurms.
• if solution should contact these areas, rinse out promptly and thoroughly with water
• wounds which involve more than the superficial layers of the skin should not be routinely treated
• repeated general skin cleansing of large body areas should not be done except when advised by a healthcare provider

Stop use and ask a doctor if

irritationm 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 about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
• a seperate nail cleaner may be used
• rinse thoroughly
• wash for an additional 3 minutes with 5 mL of product and rinse under running water
• dry thoroughly

Healthcare personnel handwash:

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

Skin wound and general skin cleansing:

• thoroughly rinse the area to be cleaned with water
• apply this minimum amount of product necessary to cover the skin or wound area and wash gently
• rinse again thoroughly

Other information

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

Inactive ingredients

cocamide DEA, fragrance, glucono-delta-lactone, hydroxyethylcellulose, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol.

Questions or comments?

call 1-800-587-3721 Monday through Friday 8:00 AM to 4:30 PM CST

OTHER SAFETY INFORMATION

Laundering/Cleaning Instrucitons: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach. Rinse completely and use only non-chlorine detergents.

PRINCIPAL DISPLAY PANEL

NDC: 11822-0116-5

daylogic

ADVANCED

ANTIMICROBIAL

handwash

4% CHLORHEXIDINE GLUCONATE

Antiseptic Solution

Clinically Proven to Reduce Bacteria on the Skin

FDA Approved Formula

Used by Healthcare Professionals

NO PHTHALATES

NO TRICLOSAN

DYE FREE

4DAY08BTLLBL

8 FL OZ (237 mL)

INGREDIENTS AND APPEARANCE

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 11822-0116
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
COCO DIETHANOLAMIDE (UNII: 92005F972D)
PEG-75 LANOLIN (UNII: 09179OX7TB)
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16)
WATER (UNII: 059QF0KO0R)
GLUCONOLACTONE (UNII: WQ29KQ9POT)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
TRIDECYL ALCOHOL (UNII: 8I9428H868)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 11822-0116-5	237 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/25/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	03/25/2021

Labeler - Rite Aid (014578892)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc		007470579	manufacture(11822-0116)