POVIDONE IODINE PREP SOLUTION STERILE- povidone-iodine solution

Povidone Iodine Prep Solution Sterile by

Drug Labeling and Warnings

Povidone Iodine Prep Solution Sterile by is a Otc medication manufactured, distributed, or labeled by Jianerkang Medical Co., Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient

Povidone-iodine USP 10%

Purpose

Antiseptic

Use

Antiseptic skin preparation

Warnings

For external use only

Do not use

• if allergic to iodine
• in the eyes

Ask a doctor before use if injuries are

• deep or puncture wounds
• serious burns

Stop use and ask a doctor if

• infection occurs
• redness, irritation, swelling or pain persists or increases

Store at room temperature.  Avoid pooling beneath patientAvoid excessive heat.

Keep out of reach of children.

In case of accidental ingestion, seek professinoal assistance or consult a poion control center immediately

Directions

Apply locally as needed

Other information

• 1% titratable iodine
• for hospital or professional use only

Inactive ingredients

Purified water, Glycerin, Nonyl nonoxynol-10

Package Labeling:

INGREDIENTS AND APPEARANCE

POVIDONE IODINE PREP SOLUTION STERILE 
povidone-iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-0013
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-0013-1	30 mL in 1 POUCH; Type 0: Not a Combination Product	01/01/2021

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	505G(a)(3)	01/01/2021

Labeler - Jianerkang Medical Co., Ltd (530968767)