POVIDONE IODINE TOPICAL SOLUTION PAINT- povidone iodine 10% liquid

Povidone Iodine Topical Solution Paint by

Drug Labeling and Warnings

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

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Drug Facts

Active Ingredient

Povidone-Iodine, USP 10%

(1.0% available iodine)

Purpose

patient preoperative prep

Use

prepping intact skin and mucous membranes prior to sugery

Warnings

for external use only

avoid use on persons allergic to iodine

Stop using this product and ask a doctor if

• skin shows symptoms of irritation, sensitivity, redness, pain or swelling

Keep out of reach of children.

if swallowed, get medical help or contact a Poison Control Center right away

Directions

Patient preoperative prep

• apply solution to operative site following povidone iodine scrub application
• using a circular motion, start at incision site and move outward
• remove all soiled underdrapes
• do no allow solution to pool

Other information

• store at room temperature
• avoid excessive heat (above 104 degrees F/40 degrees C)
• protect from freezing
• latex free

Inactive Ingredients

Purified Water, nonylphenol ethoxylate, glycerol

Package Labeling

INGREDIENTS AND APPEARANCE

POVIDONE IODINE TOPICAL SOLUTION PAINT 
povidone iodine 10% liquid

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-1040
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)
NONOXYNOL-9 (UNII: 48Q180SH9T)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-1040-1	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2015	08/21/2018
2	NDC: 34645-1040-2	59 mL in 1 BOTTLE; Type 0: Not a Combination Product	03/31/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333A	03/31/2015

Labeler - Jiangsu Province Jianerkang Medical Dressing Co., Ltd. (530968767)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Province Jianerkang Medical Dressing Co., Ltd.		530968767	manufacture(34645-1040)