Iodine Sepp

Dosage form: tincture
Ingredients: IODINE 20mg in 1mL
Labeler: CareFusion 213 LLC
NDC Code: 54365-161

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.

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. Flammable: Keep away from fire or flame.

Do not use with electrocautery procedures

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
1
remove the applicator wrapper. Do not touch the applicator tip.
2
with the applicator tip facing downward, pinch the barrel of the applicator ONCE to release the antiseptic.
3
Press the applicator tip against the patient’s skin. With gentle back and forth actions apply solution to the treatment area.
4
the area covered should be allowed to dry naturally.
5
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

Cat. No. 260261

NDC 54365-161-01

Single Use

Not made with natural rubber latex.

Applicator is sterile if package is intact.

200 Applicators

0.02 fl. oz. (0.67ml) each

IODINE SEPP 
iodine tincture
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54365-161
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IODINE (IODINE) IODINE20 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
SODIUM IODIDE 
ALCOHOL 
WATER 
Packaging
#Item CodePackage Description
1NDC:54365-161-01200 POUCH in 1 CARTON
11 APPLICATOR in 1 POUCH
10.67 mL in 1 APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A02/01/1988
Labeler - CareFusion 213 LLC (826496312)
Registrant - CareFusion 2200, Inc (832696038)
Establishment
NameAddressID/FEIOperations
CareFusion 213 LLC826496312LABEL(54365-161), MANUFACTURE(54365-161), PACK(54365-161)

Revised: 05/2013
 
CareFusion 213 LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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