SCRUB CARE POVIDONE IODINE CLEANSING SCRUB- 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 Cleansing Scrub

Active ingredient

Povidone-Iodine, USP 7.5% (0.75% available iodine)

Purpose

Antiseptic

Uses

For surgical hand scrub
For preparation of skin and mucous membranes prior to surgery
For hand washing to reduce bacteria on skin

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

Surgical hand scrub: Wet hands and forearms with water; scrub for 3 minutes with about 5 ml of scrub and a wet brush; pay close attention to the nails, cuticles, and interdigital spaces; rinse thoroughly with running water; repeat
Patient preoperative prep: Use full strength; apply solution saturated sponge to operative site; scrub in a circular motion for 5 minutes starting at incision site and move outward; blot with sterile towel; follow with application of topical solution
For handwashing: Apply ample amount of solution to wet hands; wash in vigorous manner for 15 seconds; rinse and dry hands

Other information

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

Inactive ingredients

Alkyl Polyglucoside, Citric Acid, 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 Scrub Principal Label

Scrub Care PVP-I Scrub 4 oz Label

SCRUB CARE POVIDONE IODINE CLEANSING SCRUB 
povidone iodine solution
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:50425-010
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE 7.5 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
WATER (UNII: 059QF0KO0R)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:50425-010-59 59 mL in 1 BOTTLE
2 NDC:50425-010-98 118 mL in 1 BOTTLE
3 NDC:50425-010-97 236 mL in 1 BOTTLE
4 NDC:50425-010-96 472 mL in 1 BOTTLE
5 NDC:50425-010-95 944 mL in 1 BOTTLE
6 NDC:50425-010-94 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
Productos Urologos de Mexico, S.A. de C.V. 812552219 LABEL(50425-010) , PACK(50425-010)

Revised: 8/2012
Document Id: 9f3a8e4f-c833-4e1c-9c41-04ad164a8105
Set id: 19182492-4cde-481f-bac0-7b47ac8cad4e
Version: 5
Effective Time: 20120801
 
CareFusion 213 LLC