POVIDONE-IODINE PREP PAD- povidone-iodine swab
Nantong Sirius Packing Products 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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72059-002

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

Directions

Apple locally as needed.

Other information

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

Use

Antiseptic for preparation of the skin

Inactive Ingredients

Purified Water

002

POVIDONE-IODINE PREP PAD
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:72059-002
Route of Administration	PERCUTANEOUS

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:72059-002-01	1 in 1 PACKAGE; Type 0: Not a Combination Product	02/01/2018

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	02/01/2018

Labeler - Nantong Sirius Packing Products Co., Ltd. (546071515)

Name	Address	ID/FEI	Business Operations
Establishment
Nantong Sirius Packing Products Co., Ltd.		546071515	manufacture(72059-002)

Revised: 2/2018

Document Id: 6428a664-9e20-83c5-e053-2991aa0a4098

Set id: 64289d57-530b-60e3-e053-2a91aa0aa17c

Version: 1

Effective Time: 20180201

Nantong Sirius Packing Products Co., Ltd.