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 Kinray Inc., Xttrium Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active Ingredients

Chlorhexidine Gluconate 4% Solution

Purpose

Antiseptic

Uses

Healthcare Professional handwash: helps reduce bacteria that potentially can cause disease..

Patient preoperative skin preparation: for the preparation of the patient's skin prior to surgery

Skin wound and genral skin cleaning

Warnings

for external use only

Do not use

• if you are alleric to chlorhexidine gluconate or any ohter ingredient
• in contact with meninges
• in genital area
• as a preoperative skin preparation of the head or face

When using this product

• keep out of eyes, ears, an mouth. Maycause seriously and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when installed in the middle ear thru 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 the underlying condition makes it necessary to reduce the bacterial population of skin

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

Warning

This product contains a chemical known to the State of California to cause Cancer.

Directions

use with care in premature infants or infants under 2 months of age. These products may cause irritation or chemical burns.

Healthcare personnel handwash:

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

Patient preoperative skin preparation:

• apply product librally to surgical site and swab for at least 2 minutes and dry with a sterile towel
• repeat procedure for an additional 2 minutes and dry with a sterile towel

Skin wound and normal skin cleansing:

• thoroughly rinse the area to be cleaned with water
• apply the 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, isopropyl alcohol, lauramine oxide, PEG-75 lanolin, purified water, tridecyl alcohol

Questions of comments?

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

Package label and principal display panel

Preferred Plus Pharmacy

NDC: 61715-072-08

Antiseptic Skin Cleanser

(Chlorhexidine Gluconate 4% solution)

Antiseptic/Antimicrobial Skin Cleanser

for external use only

8FL OZ. (237 mL)

Do no use if seal is broken or missing

INGREDIENTS AND APPEARANCE

ANTISEPTIC SKIN CLEANSER 
chlorhexidine gluconate 4% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61715-072
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L)	CHLORHEXIDINE GLUCONATE	4 mg  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)
ISOPROPYL ALCOHOL (UNII: ND2M416302)
WATER (UNII: 059QF0KO0R)
TRIDECYL ALCOHOL (UNII: 8I9428H868)
GLUCONOLACTONE (UNII: WQ29KQ9POT)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61715-072-08	237 mL in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
NDA	NDA019125	08/03/2013

Labeler - Kinray Inc. (012574513)

Registrant - Xttrium Laboratories, Inc. (007470579)

Establishment
Name	Address	ID/FEI	Business Operations
Xttrium Laboratories, Inc.		007470579	manufacture(61715-072)