Label: APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE- chlorhexidine gluconate solution
-
Contains inactivated NDC Code(s)
NDC Code(s): 52380-1272-4, 52380-1272-6, 52380-1272-7, 52380-1272-8, view more52380-1272-9 - Packager: Aplicare, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 11, 2015
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
-
Uses
- surgical hand scrub: significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care
- healthcare personnel 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 general skin cleansing
-
Warnings
For external use only
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
- single use when used for patient preoperative skin preparation
- 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
-
Directions
- use with care on 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 with 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
Healthcare personnel handwash:
- 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
Patient preoperative skin preparation:
- apply product liberally 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 general 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
- Inactive ingredients
- QUESTIONS
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
APLICARE ANTISEPTIC CHLORHEXIDINE GLUCONATE
chlorhexidine gluconate solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:52380-1272 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) GLUCONOLACTONE (UNII: WQ29KQ9POT) 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:52380-1272-4 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:52380-1272-8 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:52380-1272-6 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 4 NDC:52380-1272-7 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 5 NDC:52380-1272-9 3800 mL in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 09/01/1998 Labeler - Aplicare, Inc. (107255002)
