SCRUB CARE POVIDONE IODINE TOPICAL PAINT- 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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Scrub Care® Povidone Iodine Topical Solution Paint

Active ingredient

Povidone-Iodine, USP 10% (1.0% available iodine)

Purpose

Antiseptic

Uses

Prepping intact skin and mucous membranes prior to surgery
Helps reduce bacteria that potentially can cause skin infection

Warnings

For external use only
Avoid use on persons allergic to iodine
Do not use in the eyes
Discontinue use if irritation and redness develop. If condition persist for more than 72 hours consult a doctor.

Stop use and ask a doctor if

Skin shows symptoms of irritation, sensitivity, redness, pain or swelling
In case of deep puncture wounds or serious burns

Keep out of reach of children.

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

Directions

Use full strength
Apply solution to operative site following povidone iodine scrub application
Using a circular motion, start at incision site and move outward
Remove all soiled underdrapes
Do not allow solution to pool

Other information

Store at room temperature
Avoid excessive heat (above 104°F/40°C)
Protect from freezing
Latex Free

Inactive ingredients

Citric Acid, Glycerol, Nonylphenol Ethoxylate, Purified Water, Sodium Hydroxide

Questions?

Report serious side effects, call: 1-800-523-0502 Mon.-Fri. 8 AM-5 PM CST

Package/Label Principal Display Panel

PVPI Paint Prinicipal Label

Scrub Care 1 gal PVPI Paint Label

SCRUB CARE POVIDONE IODINE TOPICAL PAINT 
providone iodine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50425-011
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 10 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50425-011-59 59 mL in 1 BOTTLE
2 NDC:50425-011-98 118 mL in 1 BOTTLE
3 NDC:50425-011-97 236 mL in 1 BOTTLE
4 NDC:50425-011-96 472 mL in 1 BOTTLE
5 NDC:50425-011-95 944 mL in 1 BOTTLE
6 NDC:50425-011-94 3785 mL in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part333A 01/01/2001
Labeler - CareFusion 213 LLC (831684456)
Registrant - CareFusion 213 LLC (831684456)
Establishment
Name Address ID/FEI Business Operations
Thatcher Company 041307356 MANUFACTURE(50425-011)
Establishment
Name Address ID/FEI Business Operations
Productos Urologos de Mexico, S.A. de C.V 812552219 LABEL(50425-011) , PACK(50425-011)

Revised: 8/2012
Document Id: 790b6520-aa91-4192-82d9-49f01fee0e8e
Set id: fbe92fa9-273c-45be-a46d-437587507bee
Version: 5
Effective Time: 20120801
 
CareFusion 213 LLC