Label: ANTISEPTIC SKIN CLEANSER- chlorhexidine gluconate liquid
- NDC Code(s): 70000-0407-1
- Packager: Cardinal Health
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated November 2, 2023
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- Official Label (Printer Friendly)
- Drug Facts
- Active ingredient
- Purpose
- Uses
- Warnings
- Do not use
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When using this product
- keep out of eyes, ears and mouth. May cause serious and permenant 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 advised by a health care provider
- Stop use and ask a doctor if
- Keep out of reach of children
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Directions
- use with care in premature infants or infants under 2 months of age. These products may cause irritation of 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:
- 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?
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OTHER SAFETY INFORMATION
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 districuted by Regent Medical Limited (United Kingdom Corp.), owner of the registered trademark Hibiclens ®.
WARNING: Cancer - www.P65Warnings.ca.gov
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PDP
NDC 70000-0407-1
Leader
Antisptic Skin Cleanser
Chlorhexidine Gluconate 4% Solution
Antiseptic/Antimicrobial Skin Cleanser
Great For Hand Hygiene
For Skin Wound and General Skin Cleansing
Compare To Hibiclens® active ingredients*
For External Use Only
8 fl (237 mL)
Tampering evident:
Do not use if shrink seal neackband is broken or missing
CIN 5454889 REV. 8/23
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INGREDIENTS AND APPEARANCE
ANTISEPTIC SKIN CLEANSER
chlorhexidine gluconate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:70000-0407 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 LAURAMINE OXIDE (UNII: 4F6FC4MI8W) PEG-75 LANOLIN (UNII: 09179OX7TB) TRIDECYL ALCOHOL (UNII: 8I9428H868) GLUCONOLACTONE (UNII: WQ29KQ9POT) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) ISOPROPYL ALCOHOL (UNII: ND2M416302) COCO DIETHANOLAMIDE (UNII: 92005F972D) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:70000-0407-1 237 mL in 1 BOTTLE; 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 - Cardinal Health (063997360) Registrant - Xttrium Laboratories, Inc (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc 007470579 manufacture(70000-0407)