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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Active ingredient

Iodine 2% 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. Flammable: Keep away from fire or flame

Do not use with electrocautery procedures

Do Not Use

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 Sepp. Hold in downward position and pinch center of Sepp to crush ampule.
  • use repeated back-and-forth strokes of the applicator for approximately 30 seconds or apply iodine tincture to venipuncture site starting at center and moving outward in concentric circles to periphery. Allow to dry.
  • proceed with the collection of blood
  • discard unused components

Other information

  • store below 30 °C (86 °F)

Inactive ingredients

  • USP purified water
  • ethyl alcohol
  • sodium iodide USP

Questions?

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

Package/Label Principal Display Panel

Iodine Tincture Sepp Carton Display Panel

NDC 54365-161-01

Single Use

Latex Free

Contents STERILE if primary container is intact

200 Applicators

Net 0.67 ml each

Iodine Tincture 2% SEPPS®

CareFusion

Leawood, KS 66211

1.800.523.0502

Made in USA

Store below 30 °C or 86 °F

For external use only

For hospital and professional use only

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
ALCOHOL0.47 mL  in 1 mL
SODIUM IODIDE23.5 mg  in 1 mL
WATER0.4865 mL  in 1 mL
Packaging
#Item CodePackage Description
1NDC:54365-161-01200 in 1 CARTON
11 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 (831684456)
Establishment
NameAddressID/FEIBusiness Operations
CareFusion 213 LLC830430810ANALYSIS, LABEL, MANUFACTURE, PACK

Revised: 05/2010
Document Id: 37293532-58d7-4772-aeeb-f6f14bf86574
Set id: 98993ea2-2424-4cfd-af04-7e018c5d7e02
Version: 5
Effective Time: 20100511
 
CareFusion 213 LLC