POVIDONE-IODINE PREP PAD- povidone-iodine swab
Davemed Healthcare 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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Povidone-Iodine

Active Ingredient

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

Purpose

Antiseptic

Use

Antiseptic for preparation of the skin.

Non-sterile Solution

Applicator is sterile if package is intact

Warnings

For external use only.

Discontinue use if irritation and redness develop.

Keep out of reach of Children.

Directions

Apply locally as needed.

Inactive ingredients

Purified Water

label

POVIDONE-IODINE PREP PAD
povidone-iodine swab

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:70897-006
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	0.1 mg

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:70897-006-01	1 in 1 PACKET; Type 0: Not a Combination Product	01/24/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	01/24/2019

Labeler - Davemed Healthcare Co., Ltd (529128716)

Name	Address	ID/FEI	Business Operations
Establishment
Davemed Healthcare Co., Ltd		529128716	manufacture(70897-006)

Revised: 1/2019

Document Id: 803aa01a-6558-5107-e053-2a91aa0a6927

Set id: 803aa01a-6557-5107-e053-2a91aa0a6927

Version: 1

Effective Time: 20190124

Davemed Healthcare Co., Ltd