IODINE SEPP- iodine tincture
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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Iodine Tincture 2%

Active ingredient

Iodine 2% v/v, USP

Purpose

Antiseptic

Use

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 ethyl alcohol or iodine

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 the 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 a single use.

Other information

store below 30 °C (86 °F)

Inactive ingredients

Ethyl alcohol, USP purified water, sodium iodide USP

Questions?

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

Package/Label Principal Display Panel

Carton label

Cat. No. 260261

NDC 54365-161-01

Patient Preoperative Skin Preparation

Non-sterile Solution

Applicator is sterile if package is intact

Single Use

Not made with natural rubber latex.

200 Applicators

0.02 fl. oz. (0.67ml) each

IODINE SEPP
iodine tincture

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:54365-161
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	20 mg in 1 mL

Ingredient Name	Strength
Inactive Ingredients
SODIUM IODIDE (UNII: F5WR8N145C)
ALCOHOL (UNII: 3K9958V90M)
WATER (UNII: 059QF0KO0R)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:54365-161-01	200 in 1 CARTON	02/01/1988	11/06/2016
1		1 in 1 POUCH
1		0.67 mL in 1 APPLICATOR; 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	11/06/2016

Labeler - CareFusion 213 LLC (826496312)

Registrant - CareFusion 2200, Inc (832696038)

Name	Address	ID/FEI	Business Operations
Establishment
CareFusion 213 LLC		826496312	label(54365-161) , manufacture(54365-161) , pack(54365-161)

Revised: 12/2017

Document Id: 5f99d233-544f-265b-e053-2a91aa0a6d48

Set id: 98993ea2-2424-4cfd-af04-7e018c5d7e02

Version: 8

Effective Time: 20171207

CareFusion 213 LLC