Label: HIBICLENS- chlorhexidine gluconate 4% solution
- NDC Code(s): 0116-0575-41
- Packager: Xttrium Laboratories, Inc.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated January 30, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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Warnings
For external use only
Allergy alert
This product may cuase 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 the 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 contact occurs in any of these areas, rinse with cold water right away
- wounds which involve more than the superficial layers of the skin should not be routinely treated
- repeated general cleansing of large body areas should not be done except when advised by a health care provider
- Stop use and ask 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.
- skin wound and general skin cleansing.
Thoroughly rinse the area to be cleansed with water. Apply the minimum amount of the product necessary to cover the skin or wound area and wash gently. Rinse thoroughly.
- surgical hand scrub.
Wet hands and forearms with water. Scrub for 3 minutes with about 5 mL (4 pumps) of the product with a brush. Rinse thoroughly under running water. Repeat. Dry thoroughly.
- healthcare personnel handwash.
Wet hands with water. Dispense about 5 mL (4 pumps) of the product into cupped hands and wash in a vigorous manner for 15 seconds. Rinse and dry thoroughly.
- Other information
- INACTIVE INGREDIENT
- Questions?
- Laundering and Cleaning Instructions
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
HIBICLENS
chlorhexidine gluconate 4% solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0116-0575 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CHLORHEXIDINE GLUCONATE (UNII: MOR84MUD8E) (CHLORHEXIDINE - UNII:R4KO0DY52L) CHLORHEXIDINE GLUCONATE 213 g in 1000 mL Inactive Ingredients Ingredient Name Strength LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) GLUCONOLACTONE (UNII: WQ29KQ9POT) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLOXAMER 237 (UNII: JT3U72U71K) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0116-0575-41 118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product 01/30/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017768 01/30/2024 Labeler - Xttrium Laboratories, Inc. (007470579) Registrant - Xttrium Laboratories, Inc. (007470579) Establishment Name Address ID/FEI Business Operations Xttrium Laboratories, Inc. 007470579 manufacture(0116-0575)
