Label: CLINICLEAN- chlorhexidine gluconate 4% solution
- NDC Code(s): 0116-0901-08, 0116-0901-16, 0116-0901-32
- 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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- ACTIVE INGREDIENT
- Purpose
- Uses
-
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
- 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 advised by a health care provider
-
Direction
- 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 about 5 mL of product and a wet brush paying close attention to the nails, cuticles, and interdigital spaces
- a separate nail cleaner may be used
- rinse throughly
- wash for an additional 3 minutes with 5 mL of product and rinse under running water
- dry thoroughly
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 or comments?
- Laundry/Cleaning Instrucations
-
Packaging
NDC 69464-901-08
REF 90208
CliniClean
Chlorhexidine Gluconate 4%
Antiseptic/Antimicrobial Solution
Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser
Net Contents: 8 fl oz (237 mL)
DYE FREE
Manufactured for:
HR Pharmaceutials, Inc.
York, PA 17402
cliniclean.com
4171 Rev 1
(10/2023)
4HRP08BTLLBLA
NDC 69464-901-16
REF 90316
CliniClean
Chlorhexidine Gluconate 4%
Antiseptic/Antimicrobial Solution
Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser
Net Contents: 16 fl oz (473 mL)
DYE FREE
Manufactured for:
HR Pharmaceutials, Inc.
York, PA 17402
cliniclean.com
4172 Rev 1
(10/2023)
4HRP16BTLLBLA
NDC 69464-901-32
REF 90432
CliniClean
Chlorhexidine Gluconate 4%
Antiseptic/Antimicrobial Solution
Surgical Hand Scrub, Healthcare Personnel Hand Wash, General Skin & Wound Cleanser
Net Contents: 32 fl oz (946 mL)
DYE FREE
Manufactured for:
HR Pharmaceutials, Inc.
York, PA 17402
cliniclean.com
Rev 4171-0 (02/2023)
4HRP32BTLLBL
-
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 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) WATER (UNII: 059QF0KO0R) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-0901-08 237 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 2 NDC:0116-0901-16 473 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 3 NDC:0116-0901-32 946 mL in 1 BOTTLE; Type 0: Not a Combination Product 03/23/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA019125 03/23/2023 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-0901)