POVIDONE IODINE PREP- povidone iodine solution

Povidone Iodine Prep by

Drug Labeling and Warnings

Povidone Iodine Prep by is a Otc medication manufactured, distributed, or labeled by Sion Biotext Medical Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

Povidone-Iodine 10% (equivalent to 1% titrable Iodine)

Purpose

Antiseptic

Uses

• First Aid for minor cuts, scrapes, and burns (helps prevent infection)
• Preoperative skin prep (reduces bacteria)

Warning

For external use only.

Do Not Use:

• In eyes
• More than week (unless advised by a doctor)
• On those allergic/senstiive to iodine
• Over large body areas

Ask a doctor before use if:

• Deep or puncure wounds.
• Animal Bites
• Serious wounds

Stop use and ask a doctor if:

• Irritation or redness appears
• Condition lasts more than 72 hours

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center immediately

Directions

As a first aid antiseptic:

• Clean affected area
• Apply a fingertip-sized amount 1-3 tmes daily
• Cover with a sterile bandage if desired (allow to dry first)

For preoperative patient skin preparation:

• Clean area
• Apply before surgery
• Let dry at least 2 minutes before draping
• Remove soiled underdrapes
• Avoid pooling

Other Information

• Store at room temperature 20-25° C (68-77°F)
• Avoid excessive heat
• Not made with natural rubber latex

Inactive Ingredients

Citric acid, dibasic sodium phosphate, glycerin, polysorbate 80 (tween 80), sodium citrate, water.

PRINCIPAL DISPLAY PANEL

NDC: 68786-010-89

SIONBIOTEXT

Prep Solution Topical Antiseptic Microbicide

10% POVIDONE IODINE

NET CONTENT

3 fl.oz. (89 ml)

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP 
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 68786-010
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM CITRATE (UNII: 1Q73Q2JULR)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 68786-010-89	89 mL in 1 PACKET; Type 0: Not a Combination Product	05/06/2025

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M003	05/06/2025

Labeler - Sion Biotext Medical Ltd (532775194)

Registrant - Sion Biotext Medical Ltd (532775194)