POVIDONE IODINE IMPREGNATED- povidone iodine sponge

Povidone Iodine Impregnated by

Drug Labeling and Warnings

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

Drug Details [pdf]

Active Ingredients

Povidone Iodine, USP 10% (1.0% available Iodine)

Purpose

Antiseptic

Uses

For preparation of skin and mucous membranes prior to surgery

Warnings

For external use only

Avoid use on persons allergic to iodine

Stop use 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 Poison Control Center right away

Directions

open pouch at tear notch

use sponge sticks to prep desired area

Other information

store at room temperature
avoid excessive heat (above 104 oF/40 oC)
protect from freezing
latex free

Inactive Ingredients

purified water, hydroxyethylcellulose, Nonylph

Package Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE IMPREGNATED 
povidone iodine sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-1030
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.1 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%) (UNII: R33S7TK2EP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-1030-1	10 in 1 BOX	03/03/2015
1		120 mL in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part333E	03/03/2015

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

Registrant - Jiangsu Province JianErKang Medical Dressing Co. ,Ltd. (530968767)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.		530968767	manufacture(34645-1030)