Label: APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution
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Contains inactivated NDC Code(s)
NDC Code(s): 52380-1274-4, 52380-1274-6, 52380-1274-7, 52380-1274-8, view more52380-1274-9 - Packager: Aplicare, Inc.
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated June 9, 2010
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ACTIVE INGREDIENT
Active ingredient
Chlorhexidine Gluconate 2% solution
Purpose
Surgical hand scrub
Healthcare personnel handwash
Patient preoperative skin preparation
Skin wound and general skin cleansing
Do not use
- if you are allergic to chlorhexidine gluconate or any other ingredients
- in contact with meninges
- in the genital area
- as a preoperative skin prep of the head or face
When using this product
- keep out of eyes, ears and mouth. May cause serious and permanent eye injury if placed or kept in the eye during surgical procedures or may cause deafness when installed in the middle ear through perforated ear drums.
- 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 the skin
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DOSAGE & ADMINISTRATION
Directions
Surgical hand scrub
- wet hands and forearms under running 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 separate 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
- wet hands with water
- dispense about 5 ml of product into cupped hands and wash in a vigorous manner for 15 seconds
- rinse and dry thoroughly
- apply product liberally to surgical site and swab for at least 2 minutes
- dry with a sterile towel
- repeat procedure for an additional 2 minutes and dry with a sterile towel
- 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
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-1274 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine Gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine Gluconate 2 g in 100 g Inactive Ingredients Ingredient Name Strength Anhydrous Citric Acid (UNII: XF417D3PSL) Cocamide Diethanolamine (UNII: 92005F972D) Hydroxyethyl Cellulose (140 CPS AT 5%) (UNII: 8136Y38GY5) Isopropyl Alcohol (UNII: ND2M416302) Lauramine Oxide (UNII: 4F6FC4MI8W) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:52380-1274-4 120 g in 1 BOTTLE 2 NDC:52380-1274-8 240 g in 1 BOTTLE 3 NDC:52380-1274-6 480 g in 1 BOTTLE 4 NDC:52380-1274-7 960 g in 1 BOTTLE 5 NDC:52380-1274-9 3785 g in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019422 09/01/1998 Labeler - Aplicare, Inc. (107255002) Establishment Name Address ID/FEI Business Operations Aplicare, Inc. 058377631 repack
