POVIDONE IODINE SURGICAL SCRUB- povidone iodine sponge
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Drug Facts

Active Ingredients

9% Povidone Iodine, USP Cleansing Solution

Purpose

Antiseptic

Use

For cleansing hands and arms prior to surgery

Warnings

For external use only

Do not use in the eyes

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

Wet hands and forearms with water

Clean under nails with nail cleaner

Scrub for 3 minutes with the impregnated brush

Pay close attention to the nails, cuticles, and interdigital spaces

Rinse thoroughly with running water

Repeat

Other Information

Store at room temperature

Avoid excessive heat above 40 o C (104 oF)

Protect from freezing

Latex free

Inactive Ingredients

Alkyl Polyglucoside, Citric Acid, Glycerin, Hydroxyethylcellulose, Purified Water, Sodium Hydroxide

Package Label

Pouch Label

POVIDONE IODINE SURGICAL SCRUB
povidone iodine sponge

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34645-4012
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	90 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34645-4012-7	12 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	01/01/2010	08/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	01/01/2010	08/21/2018

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

Name	Address	ID/FEI	Business Operations
Establishment
Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.		530968767	manufacture(34645-4012)

Revised: 8/2018

Document Id: 73f0aede-a6a5-17ed-e053-2991aa0abddf

Set id: 2c612006-3da0-4ae4-9dbb-aa3a382423b8

Version: 5

Effective Time: 20180821

Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.