PROVIDONE-IODINE PREP PADS- povidone-iodine patch
Cardinal Health

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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Providone-Iodine Prep Pads

Drug Facts

Active ingredient

Povidone-Iodine USP 10%

Purpose

First Aid Antibiotic

Use

first aid to help prevent skin infection in minor cuts, scrapes, and burns

Warnings

For external use only • Do not apply to persons allergic to iodine

Do not use

in the eyes or apply over large areas of the body • longer than one week unless directed by a doctor

Ask a doctor before use if you have

deep or puncture wounds • animal bites • serious burns

Stop use and ask a doctor if

condition persists or gets worse

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away

Directions

clean the affected area • apply a small amount of this product on the area 1-3 times daily • may be covered with a sterile bandage
• if bandaged, let dry first

Other information

store at 10°-30°C (50°-86°F)

Inactive ingredients

purified water

Product Label

Box

PROVIDONE-IODINE PREP PADS
povidone-iodine patch

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:63517-212
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	100 mg in 1 g

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:63517-212-02	100 in 1 BOX	08/03/2016	01/01/2018
1		0.6 g in 1 PATCH; Type 4: Device Coated/Impregnated/Otherwise Combined with Drug

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	08/03/2016	01/01/2018

Labeler - Cardinal Health (097537435)

Revised: 12/2017

Document Id: 61705e66-4ad4-ba27-e053-2a91aa0a3d84

Set id: 52becbe9-713c-4d7d-8325-7e875866b53d

Version: 4

Effective Time: 20171228

Cardinal Health