POVIDONE IODINE- povidone-iodine swab
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 Ingredient

Povidone Iodine USP, 10%

Purpose

Antiseptic

Use
Antiseptic Skin Preparation

Warnings: Do not use if allergic to Iodine

Stop use and ask a doctor if

redness, irritation, swelling or pain persists or increases

infection occurs

injuries are deep or puncture wounds or serious burns

Keep out of reach of children.

In case of accidental ingestion, seek professional assistance or consult a poison control center immediately.

For external use only.

Directions

Apply locally as needed

Other information

1% titratable iodine

latex free

Inactive ingredients

Disodium phosphate, water, Nonoxynol-10, glycerin, dimethicone, hydroxyethylcellulose

Image of Pouch Label

Pouch Label

POVIDONE IODINE
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:34645-4019
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)
GLYCERIN (UNII: PDC6A3C0OX)
NONOXYNOL-10 (UNII: K7O76887AP)
DIMETHICONE (UNII: 92RU3N3Y1O)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:34645-4019-4	2 mL in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)	03/01/2010	08/21/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	03/01/2010	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(34645-4019)

Revised: 8/2018

Document Id: 73f0d4ed-29c1-c4db-e053-2a91aa0a32b9

Set id: dadd7de6-21e0-40c7-b9ff-cbf9ecffee41

Version: 4

Effective Time: 20180821

Jiangsu Province JianErKang Medical Dressing Co. ,Ltd.