Label: HIBISTAT- chlorhexidine gluconate and isopropyl alcohol solution
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Contains inactivated NDC Code(s)
NDC Code(s): 0234-0587-17, 0234-0587-27 - Packager: Mölnlycke Health Care US, LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated April 19, 2011
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- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- Use
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Warnings
For external use only
Flammable: keep away from fire or flame.
Do not use
- if you are allergic to chlorhexidine gluconate or any other ingredients in this preparation
- as a patient preoperative skin preparation (especially on the head or face)
- 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 placed or kept in the eye during surgical procedures, 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
- Directions
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - 5mL Wipe Packet
NDC 0234-0587-17
HIBISTAT®
(0.5% Chlorhexidine
Gluconate solution
70% isopropyl alcohol w/w)Healthcare Personnel Hand Antiseptic
HIBISTAT® provides rapid bactericidal action and has
a persistent antimicrobial effect against a wide range
of microorganisms.WARNING: For external use only
Flammable: Keep away from fire or flame.
FOR PROFESSIONAL USE ONLY.MÖLNLYCKE®
HEALTH CARE1 Hand Antiseptic Wipe (5mL)
Distributed by Mölnlycke Health Care US, LLC.,
Norcross GA 30092 -
INGREDIENTS AND APPEARANCE
HIBISTAT
chlorhexidine gluconate and isopropyl alcohol solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0234-0587 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Chlorhexidine gluconate (UNII: MOR84MUD8E) (Chlorhexidine - UNII:R4KO0DY52L) Chlorhexidine gluconate 0.525 g in 5 mL Isopropyl alcohol (UNII: ND2M416302) (Isopropyl alcohol - UNII:ND2M416302) Isopropyl alcohol 70 g in 5 mL Inactive Ingredients Ingredient Name Strength Castor Oil (UNII: D5340Y2I9G) Glycerin (UNII: PDC6A3C0OX) Water (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0234-0587-17 50 in 1 CARTON 1 5 mL in 1 PACKET 2 NDC:0234-0587-27 15 in 1 CARTON 2 5 mL in 1 PACKET Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA018300 05/23/1980 Labeler - Mölnlycke Health Care US, LLC (165301032)