POVIDONE IODINE solution

Povidone Iodine by

Drug Labeling and Warnings

Povidone Iodine 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

Patient preoperative prep

use full strength

apply solution saturated sponge to operative site

scrub in circular motion for 5 minutes starting at incision site and move outward

blot with sterile towel

follow with application of topical solution

Other information

store at room temperature
avoid excessive heat (above104oF/40oC)
protect from freezing
latex free

INACTIVE INGREDIENT

Inactive Ingredients

alkyl polyglucoside, citric acid, nonoxynol - 10, purified water, sodium hydroxide

Package label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE 
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-4009
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
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
NONOXYNOL-10 (UNII: K7O76887AP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-4009-6	109 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product	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)

Establishment
Name	Address	ID/FEI	Business Operations
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.		530968767	manufacture(34645-4009)