Your browser does not support JavaScript! SCRUB CARE POVIDONE IODINE TOPICAL PAINT (PROVIDONE IODINE) SOLUTION [CAREFUSION 213 LLC]
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SCRUB CARE POVIDONE IODINE TOPICAL PAINT (providone iodine) solution
[CareFusion 213 LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

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 TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:50425-011
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POVIDONE-IODINE (IODINE) IODINE10 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
CITRIC ACID MONOHYDRATE 
GLYCERIN 
WATER 
SODIUM HYDROXIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:50425-011-5959 mL in 1 BOTTLE
2NDC:50425-011-98118 mL in 1 BOTTLE
3NDC:50425-011-97236 mL in 1 BOTTLE
4NDC:50425-011-96472 mL in 1 BOTTLE
5NDC:50425-011-95944 mL in 1 BOTTLE
6NDC:50425-011-943785 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart333A01/01/2001
Labeler - CareFusion 213 LLC (831684456)
Registrant - CareFusion 213 LLC (831684456)
Establishment
NameAddressID/FEIBusiness Operations
Thatcher Company041307356MANUFACTURE(50425-011)
Establishment
NameAddressID/FEIBusiness Operations
Productos Urologos de Mexico, S.A. de C.V812552219LABEL(50425-011), PACK(50425-011)

Revised: 8/2012
 
CareFusion 213 LLC

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