POVIDONE-IODINE PREP PAD - povidone-iodine swab
NANTONG STRIP MEDICAL SUPPLY 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.

----------

Drug Fact

Active Ingredient

POVIDONE-IODINE 10% W/v (equivalent to iodine 1%)

Purpose

Antiseptic

Warnings

For External use only.
Discontinue use if irritation and redness develop

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

Apple locally as needed.

Other information

Store at room temperature:59o-86oF(15--30℃)

Use

Antiseptic for preparation of the skin

Inactive Ingredients

Water，Citric acid, Disodium phosphate, Nonoxynol-9, Sodium Hydroxide,Purified Water

Enter section text here label of strip1

POVIDONE-IODINE PREP PAD
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35617-392
Route of Administration	PERCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	10 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	89.96 mL
Citric acid (UNII: 2968PHW8QP)	0.01 mL
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)	0.01 mL
NONOXYNOL-9 (UNII: 48Q180SH9T)	0.01 mL
Sodium Hydroxide (UNII: 55X04QC32I)	0.01 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35617-392-81	100 in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	05/17/2010

Labeler - NANTONG STRIP MEDICAL SUPPLY CO.,LTD. (546585519)

Name	Address	ID/FEI	Business Operations
Establishment
NANTONG STRIP MEDICAL SUPPLY CO.,LTD.		546585519	manufacture