Label: CLINICLEAN- chlorhexidine gluconate 4% solution
- NDC Code(s): 0116-0901-05
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 19, 2023
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- Official Label (Printer Friendly)
- 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 permanent eye injury if permitted to enter and remain in the eye or may cause deafness when instilled in the middle ear through perforated eardurms.
- 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 healthcare 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 or chemical burns.
Surgical hand scrub:
- wet hands and forearms with water
- scrub for 3 minutes with 4 full pumps (6 grams) of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
- a seperate nail cleaner may be used
- rinse thoroughly
- wash for an additional 3 minutes with 4 full pumps(6 grams) of product and rinse under running water
- dry thoroughly
Healthcare personnel handwash:
- wet hands with water
- dispense 4 full pumps (6 grams) of product into cupped hands and wash in a vigrous 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
- Questions or comments?
- Laudering/Cleaning Instructions
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Package Label
NDC 69464-901-05
REF 90604
CliniClean
Chlrohexidine Gluconate 4%
Antiseptic/Antimicrobial Solution with Foaming Pump
Surgical Hand Scrub, Heath Personnel Hand Wash, General Skin & Wound Cleanser
Net Content: 4fl oz (118 mL)
DYE FREE
Manufactured for:
HR Pharmaceuticals, Inc.
York, PA 17402
cliniclean.com
Rev 4176 Rev 2
(12/2023)
4HRP04FMBTLLBLA
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INGREDIENTS AND APPEARANCE
CLINICLEAN
chlorhexidine gluconate 4% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-0901 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 PEG-75 LANOLIN (UNII: 09179OX7TB) HYDROXYETHYL CELLULOSE (2000 CPS AT 1%) (UNII: S38J6RZN16) WATER (UNII: 059QF0KO0R) TRIDECYL ALCOHOL (UNII: 8I9428H868) GLUCONOLACTONE (UNII: WQ29KQ9POT) ISOPROPYL ALCOHOL (UNII: ND2M416302) COCO DIETHANOLAMIDE (UNII: 92005F972D) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-0901-05 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 03/15/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 03/15/2023 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc 007470579 manufacture(0116-0901)