Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid
- 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 6, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- Purpose
- Uses
-
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 seek 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
-
Directions
- 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 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
-
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.
- Questions?
-
Packaging
CVS Health Compare to the active ingredient in Hibiclens®*
NDC 59779-767-08
Chlorhexidine Gluconate 4% Solution
Antiseptic Skin Cleanser
Antiseptic Antimicrobial skin cleanser
For external use only
Dye Free
Distributed by:
CVS Pharmacy, Inc.
Woonsocket, RI 02985
©2023 CVS/pharmacy V-10220
4CVS08BTLLBLG
8FL OZ (237mL)
This product is not manufactured or distributed
by Mölnlycke Healthcare, owner of the registered
trademark Hibiclens®.
4CVS08LBL4CAD
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.ca.gov.
CVS Health Compare to the active ingredient in Hibiclens®*
NDC 59779-767-16
Chlorhexidine Gluconate 4% Solution
Antiseptic Skin Cleanser
Antiseptic Antimicrobial skin cleanser
For external use only
Dye Free
Distributed by:
CVS Pharmacy, Inc.
Woonsocket, RI 02985
© 2023 CVS/pharmacy V-10220
4CVS16BTLLBLA
16FL OZ (473mL)
This product is not manufactured or distributed
by Mölnlycke Healthcare, owner of the registered
trademark Hibiclens®.
4CVS16LBL4CAC
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.ca.gov.
CVS Health Compare to the active ingredient in Hibiclens®*
NDC 59779-767-18
Chlorhexidine Gluconate 4% Solution
Antiseptic Skin Cleanser
Antiseptic Antimicrobial skin cleanser
For external use only
Dye Free
Distributed by:
CVS Pharmacy, Inc.
Woonsocket, RI 02985
4CVS18FMBTLLBLA
18FL OZ (532mL)
© 2023 CVS/pharmacy
CVS.com® 1-800-SHOP CVSThis product is not manufactured or distributed
by Mölnlycke Healthcare, owner of the registered
trademark Hibiclens®.how2recycle.info
100% money back gurantee. CVS.com/returnpolicy
4CVS18FMLBLCAA
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.ca.gov.
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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)