PVP-IODINE SEPP- povidone iodine solution
CareFusion 213 LLC

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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PVP-Iodine 10% SEPP

Active ingredient

Povidone-Iodine 10% v/v, USP

Purpose

Antiseptic

Uses

Patient preoperative skin preparation. Helps to reduce bacteria that potentially can cause skin infection.

Warnings

For external use only.

Do not use

in the eyes
on patients with known allergies to povidone-iodine or Igepal CO-630

When using this product

keep out of eyes, ears, and mouth

Stop use and ask a doctor if

irritation, sensitization, or allergic reaction occurs. You may report side effects to FDA at 1-800-FDA-1088.

Keep Out of Reach of Children

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

Directions

remove the applicator wrapper. Do not touch the applicator tip.
with applicator tip facing downward, pinch the barrel of the applicator ONCE to release the antiseptic.
press the applicator tip against the patient’s skin. With gentle back and forth actions apply solution to the treatment area.
the area covered should be allowed to dry naturally.
discard after single use.

Other information

store below 30 °C (86 °F)

Inactive ingredients

Igepal CO 630, USP purified water

Questions?

Call 1-800-523-0502 (M-F 8 a.m.-5 p.m. CST)

Package/Label Principal Display Panel

Carton label

PVP-IODINE SEPP
povidone iodine solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54365-145
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	10 mg in 1 mL

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

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54365-145-01	200 in 1 CARTON	02/01/1988	07/25/2016
1		1 in 1 POUCH
1		0.67 mL in 1 AMPULE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part333A	02/01/1988	09/07/2016

Labeler - CareFusion 213 LLC (826496312)

Registrant - CareFusion 2200, Inc (832696038)

Name	Address	ID/FEI	Business Operations
Establishment
CareFusion 213 LLC		826496312	label(54365-145) , manufacture(54365-145) , pack(54365-145)

Revised: 12/2017

Document Id: 5f99d233-545f-265b-e053-2a91aa0a6d48

Set id: cfecd7de-fa13-493f-9997-8bbea50c671f

Version: 5

Effective Time: 20171207

CareFusion 213 LLC