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 INGREDIENT

Active Ingredients

Povidone Iodine, USP 7.5% (0.75% available Iodine)

PURPOSE

Purpose

Antiseptic

INDICATIONS & USAGE

Uses

For preparation of skin and mucous membranes prior to surgery

WARNINGS

Warnings

For external use only

Avoid use on persons allergic to iodine

STOP USE

Stop use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children

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

DOSAGE & ADMINISTRATION

Directions

open pouch at tear notch

use sponge sticks to prep desired area

Other information

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

INACTIVE INGREDIENT

Inactive Ingredients

hydroxyethylcellulose, nonoxynol - 10, purified water

Package Labeling

INGREDIENTS AND APPEARANCE

POVIDONE IODINE IMPREGNATED 
povidone iodine sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-4020
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	7.5 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
NONOXYNOL-10 (UNII: K7O76887AP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-4020-4	120 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	01/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part333C	01/01/2010

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