Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid
Contains inactivated NDC Code(s)
NDC Code(s): 61715-072-08
- Packager: Kinray Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 1, 2013
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- Official Label (Printer Friendly)
- Active Ingredients
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.
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
- Inactive ingredients
- Questions of comments?
- Package label and principal display panel
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)