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Hibistat

Mölnlycke Health Care US, LLC

HIBISTAT (0.5% Chlorhexidine Gluconate solution 70% isopropyl alcohol w/w)


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

Drug Facts

Active ingredient

Purpose

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

Hibistat

Hibistat

Chlorhexidine gluconate and Isopropyl alcohol SOLUTION

Product Information

Product Type Human otc drug label Item Code (Source) NDC:0234-0587
Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety

Ingredient Name Basis of Strength Strength
chlorhexidine gluconate CHLORHEXIDINE 0.525 g
ISOPROPYL ALCOHOL ISOPROPYL ALCOHOL 70 g

Inactive Ingredients

Ingredient Name Strength
castor oil
GLYCERIN
water

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 5 in 1 PACKET
2 5 in 1 PACKET
3 NDC:0234-0587-27 15 in 1 CARTON

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
NDA NDA018300 1980-05-23


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