Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid
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- NDC Code(s): 59779-767-08, 59779-767-16, 59779-767-18
- Packager: CVS Pharmacy, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 14, 2022
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- ACTIVE INGREDIENT
- Purpose
- Uses
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Warnings
For external use only
Allergy alert:
This product may cause a severe allergic reaction. Symptoms may include:
- wheezing
- shock
- facial swelling
- hives
- rash
If an allergic reaction occurs, stop use and eek medical help right away.
Do not use
- if you or the patient is allergic to chlorhexidine gluconate or any other ingredient in this product
- in contact with meninges
- in the genital area
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 promptly and thoroughly with water
- wound 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 advised by a health care provider
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Directions
- 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 with 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 throughly
- wash for an additional 3 minutes with 5 ml of product into cupped hands and washin a vigorous manner for 15 seconds seconds
- rinse and 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
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
- other information
- Inactive ingredients
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OTHER SAFETY INFORMATION
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
Warning: This product can expose you to coconut oil diethanolamine condensate (cocamide diethanolamine), which is known to the State of California to cause cancer. For more information go to www.P65Warnings.gov
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products. Rinse completely and use only non-chlorine detergents.
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Packaging
NDC 59779-767-08
Chlorhexidine Gluconate 4% Solution
Antiseptic Skin Cleanser
Distributed by:
CVS Pharmacy, Inc.
Woonsocket, RI 02985
4CVS08BTLLBLF
8FL OZ (237mL)
NDC 59779-767-16
Chlorhexidine Gluconate 4% Solution
Antiseptic Skin Cleanser
Distributed by:
CVS Pharmacy, Inc.
Woonsocket, RI 02985
4CVS16BTLLBLA
16FL OZ (473mL)
NDC 59779-767-18
Chlorhexidine Gluconate 4% Solution
Antiseptic Skin Cleanser
Distributed by:
CVS Pharmacy, Inc.
Woonsocket, RI 02985
4CVS18FMBTLLBL
18FL OZ (532mL)
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INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate 4% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-767 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 GLUCONOLACTONE (UNII: WQ29KQ9POT) PEG-75 LANOLIN (UNII: 09179OX7TB) TRIDECYL ALCOHOL (UNII: 8I9428H868) COCO DIETHANOLAMIDE (UNII: 92005F972D) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:59779-767-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 08/31/2011 2 NDC:59779-767-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 01/01/2017 3 NDC:59779-767-18 532 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 11/14/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 08/31/2011 Labeler - CVS Pharmacy, Inc. (062312574) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(59779-767)