Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate 4% liquid
- NDC Code(s): 63868-940-08
- Packager: Chain Drug Marketing Association Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 28, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active Ingredients
- 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
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control center right away
Stop use and ask doctor if
irritation, sensitization, or allergic reaction occurs. These may be signs of a serious condition.
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 procider
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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 5ml of product into cupped hands and wash in a vigorous manner for about 15 seconds
- rinse and dry thoroughly
Skin wound and normal 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
- Questions of comments?
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Other Information
DO NOT USE IF SAFETY SEAL IS BROKEN OR MISSING
Warning: This product contains a chemical (cocamide DEA) known to the State of California to cause cancer.
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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OTHER SAFETY INFORMATION
Warning: Cancer - www.P65Warnings.gov
Laundering/Cleaning Instructions: Chlorhexidine gluconate skin cleansers will cause stains if used with chlorine releasing products, such as chlorine bleach.
*This product is not manufactured or distributed by Mölnlycke Healthcare, owner of the registered trademark Hibiclens®.
- Package label and principal display panel
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INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate 4% liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:63868-940 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 4 mg in 100 mL Inactive Ingredients Ingredient Name Strength LAURAMINE OXIDE (UNII: 4F6FC4MI8W) COCO DIETHANOLAMIDE (UNII: 92005F972D) PEG-75 LANOLIN (UNII: 09179OX7TB) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) GLUCONOLACTONE (UNII: WQ29KQ9POT) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:63868-940-08 237 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 05/01/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 05/01/2014 Labeler - Chain Drug Marketing Association Inc. (011920774) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(63868-940)
