Label: HIBICLENS- chlorhexidine gluconate solution
- NDC Code(s): 0234-0575-40, 0234-0575-41
- Packager: Molnlycke Health Care
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated December 21, 2021
If you are a consumer or patient please visit this version.
- ACTIVE INGREDIENT
- Allergy alert:
- Do not use
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 a doctor if
- Keep out of reach of children.
- 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 ingredients
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
chlorhexidine gluconate solution
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0234-0575 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 GLUCONOLACTONE (UNII: WQ29KQ9POT) LAURAMINE OXIDE (UNII: 4F6FC4MI8W) WATER (UNII: 059QF0KO0R) FD&C RED NO. 40 (UNII: WZB9127XOA) ISOPROPYL ALCOHOL (UNII: ND2M416302) POLOXAMER 237 (UNII: JT3U72U71K) Product Characteristics Color red Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0234-0575-40 118 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/15/2016 2 NDC:0234-0575-41 118 mL in 1 BOTTLE, PUMP; Type 0: Not a Combination Product 02/01/2019 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA017768 02/15/2016 Labeler - Molnlycke Health Care (165301032)