POVIDONE-IODINE - 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 Povidone-Iodine Swabsticks

Use

Antiseptic for preparation of skin.

Purpose

Antiseptic

Cautions

For External Use Only.
Do not use:
Apply over large areas of the body, use in the eyes
Drug Facts (continued):
Stop use and ask a doctor if irritation and redness develops.
If condition persists for more than 72 hours, consult a physician.

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

Directions

Wipe injection site vigorously and discard.

Other information

Store at room temperature, 59º-86ºF(15º-30℃), avoid excessive heat.

Active Ingredient

Povidone Iodine 10% w/v (equivalent to 1%iodine)

Inactive Ingredients

Water

Enter section text here 397

POVIDONE-IODINE
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:35617-397
Route of Administration	PERCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	0.1 mL

Ingredient Name	Strength
Inactive Ingredients
WATER (UNII: 059QF0KO0R)	0.9 mL

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:35617-397-01	1 in 1 PACKAGE

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333E	06/20/2011

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

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