Label: ANTISEPTIC SKIN CLEANSER- 2% chlorhexidine gluconate solution solution
- NDC Code(s): 46122-659-36
- Packager: AmerisourceBergen Drug Corporation
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated October 6, 2020
If you are a consumer or patient please visit this version.
- Active ingredient
- Do not use
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 promply 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
- Keep out of reach of children
- 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 under running water for 30 seconds. Clean fingernails using a nailstick or similar cleaner.
- scrub for 1.5 minutes with about 8 mL of product (5 full pumps) with or without a wet brush paying close attention to the nails, cuticles, and skin between the fingers.
- rinse thoroughly under running water for 30 seconds
- wash for an additional 1.5 minutes with 8 mL (5 full pumps) of product and rinse under running water for 30 seconds
- dry thoroughly
Healthcare personnel handwash:
- wet hands with water
- dispense about 5 mL of product (3 full pumps) into cupped hands and wash in a vigorous manner for 15 seconds
- rinse and dry thoroughly
- Other information
- Inactive ingredients
- Questions or comments?
- OTHER SAFETY INFORMATION
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
2% chlorhexidine gluconate solution solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:46122-659 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 2 mg in 100 mL Inactive Ingredients Ingredient Name Strength HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46122-659-36 250 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 10/01/2020 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 10/01/2020 Labeler - AmerisourceBergen Drug Corporation (007914906) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(46122-659)