HIBISTAT- chlorhexidine gluconate and isopropyl alcohol solution

Hibistat by

Drug Labeling and Warnings

Hibistat by is a Otc medication manufactured, distributed, or labeled by Mölnlycke Health Care US, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

ACTIVE INGREDIENT

Active ingredients	Purposes
Chlorhexidine gluconate solution 0.5% w/w	Antiseptic
Isopropyl alcohol, 70% w/w	Antiseptic

Use

• Healthcare Personnel Hand Antiseptic helps reduce bacteria that potentially can cause disease.

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

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.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

• rub hands vigorously with the towelette for about 15 seconds
• pay particular attention to nails and interdigital spaces
• no watering or toweling are necessary

Inactive ingredients

castor oil, glycerin, purified water

Questions?

1-800-843-8497

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 CARE

1 Hand Antiseptic Wipe (5mL)

Distributed by Mölnlycke Health Care US, LLC.,
Norcross GA 30092

INGREDIENTS AND APPEARANCE

HIBISTAT 
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)