POVIDONE-IODINE PAD - povidone-iodine swab
Shandong Haiyan Medical Manufacture 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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Antiseptic Povidone-Iodine Prep Pad 10% Povidone-Iodine, 1% available Iodine. SHANDONG HAIYAN MEDICAL MANUFACTURE CO., LTD. www. haiyan-medical.com

Active Ingredient

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

Purpose

Antiseptic

Use

Antiseptic for preparation of the skin.

Warnings

For external use only.

Discontinue use if irritation and redness develop.

Keep out of reach of Children.

Directions

Apply locally as needed.
Other Information
Store at room temperature: 59°- 86°F(15 - 30℃)

Inactive ingredients

Purified Water

POVIDONE-IODINE PAD
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:42339-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (POVIDONE-IODINE - UNII:85H0HZU99M)	POVIDONE-IODINE	9.43 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
SODIUM PHOSPHATE (UNII: SE337SVY37)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description
Packaging
1	NDC:42339-002-01	10 in 1 CONTAINER
1		100 in 1 BOX
1		0.6 g in 1 POUCH
2	NDC:42339-002-02	100 in 1 CONTAINER
2		100 in 1 BOX
2		0.6 g in 1 POUCH

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	02/18/2012

Labeler - Shandong Haiyan Medical Manufacture Co., Ltd. (421283439)

Name	Address	ID/FEI	Business Operations
Establishment
Shandong Haiyan Medical Manufacture Co., Ltd.		421283439	manufacture