Hibistat
FDA Label NDC 0234-0587

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by M�lnlycke Health Care Us, Llc for the product Hibistat (NDC 0234-0587). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, otc - purpose, use, otc - do not use, when using this product, stop use and ask a doctor if, otc - keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposes
Chlorhexidine gluconate solution 0.5% w/wAntiseptic
Isopropyl alcohol, 70% w/wAntiseptic

Use

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

Otc - Do Not Use

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.

Otc - Keep Out Of Reach Of Children

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

Principal Display Panel (Hibistat 01)

Principal Display Panel (Hibistat 01)

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