Label: HIBISTAT- chlorhexidine gluconate and isopropyl alcohol solution
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
- DEA Schedule: None
- Marketing Status: New Drug Application
Updated April 19, 2011
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
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
Stop use and ask a doctor if
- irritation, sensitization, or allergic reaction occurs and lasts for 72 hours. These may be signs of a serious condition.
- Inactive ingredients
PRINCIPAL DISPLAY PANEL - 5mL Wipe Packet
70% isopropyl alcohol w/w)
Healthcare Personnel Hand Antiseptic
HIBISTAT® provides rapid bactericidal action and has
a persistent antimicrobial effect against a wide range
WARNING: For external use only
Flammable: Keep away from fire or flame.
FOR PROFESSIONAL USE ONLY.
1 Hand Antiseptic Wipe (5mL)
Distributed by Mölnlycke Health Care US, LLC.,
Norcross GA 30092
INGREDIENTS AND APPEARANCE
chlorhexidine gluconate and isopropyl alcohol solution
Product 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)