Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate solution
- NDC Code(s): 0116-0407-01
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 14, 2023
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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/difficulty breathing
- 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
- 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 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.
Healthcare personnel handwash:
- wet hands with water
- dispense about 5 mL of product into cupped hands and wash in a vigorous manner for about 15 seconds
- rinse and dry thoroughly
Skin wound and general skin cleansing:
- throughly 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
- Questions or comments?
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OTHER SAFETY INFORMATION
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 fo to www.P65Warnings.ca.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.
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
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INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate solutionProduct Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0116-0407 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 HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) GLUCONOLACTONE (UNII: WQ29KQ9POT) PEG-75 LANOLIN (UNII: 09179OX7TB) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-0407-01 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/01/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 01/01/2012 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-0407)
