POVIDONE IODINE SCRUB- povidone-iodine swab

Povidone Iodine Scrub by

Drug Labeling and Warnings

Povidone Iodine Scrub 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

Povidone Iodine USP, 10% W/V (equivalent to 1% titratable iodine)

Purpose

Antiseptic

INDICATIONS & USAGE

Use
Health-care antiseptic for preparation of the skin prior to surgery
First aid antiseptic to help prevent the risk of skin infection in minor cuts, scrapes, and burns

WARNINGS

Warnings
For external use only

DO NOT USE

Do not
use in the eyes
use on individuals who are allergic or sensitive to iodine
apply over larger areas of the body
use as a first aid antiseptic longer than 1 week unless by a doctor

DO NOT USE

Discontinue use
if irritation and redness develop, consult a doctor in case of
deep or puncture wounds
animal bites
serious burns

DO NOT USE

Stop use and consult a doctor

if the condition persists or gets worse

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children
If swallowed, get medical help or contact a Poison Control Center right away

Directions

For preparation of the skin prior to surgery

clean the affected area, remove swab by stick
apply to the operative site prior to surgery

For use as a first aid antiseptic
clean the affected area
apply a small amount of this products on the area 1-3 times daily
may be covered with a sterile bandage
if bandaged, let dry first

Other information

store at room temperature: 15o - 30oC (59o-86oF)

Inactive ingredients

citric acid, purified water, sodium hydroxide, Nonoxynol-10, glycerin

PRINCIPAL DISPLAY PANEL

Image of Pouch Label

INGREDIENTS AND APPEARANCE

POVIDONE IODINE SCRUB 
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 34645-4050
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
WATER (UNII: 059QF0KO0R)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
NONOXYNOL-10 (UNII: K7O76887AP)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 34645-4050-3	6 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)