SCRUB CARE POVIDONE IODINE CLEANSING SCRUB- povidone iodine solution

Scrub Care Povidone Iodine Cleansing Scrub by

Drug Labeling and Warnings

Scrub Care Povidone Iodine Cleansing Scrub by is a Otc medication manufactured, distributed, or labeled by CareFusion 213 LLC, Becton, Dickinson and Company, Thatcher Company. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient

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

Purpose

Antiseptic

Uses

• Surgical Hand Scrub: Significantly reduces the number of micro-organisms on the hands and forearms prior to surgery or patient care.
• Patient Preoperative Skin Preparation: for preparation of skin prior to surgery.Helps reduce bacteria that potentially can cause skin infection.
• Antiseptic Handwash: for hand washing to reduce bacteria on skin

Warnings

For external use only

Do not use

• in the eyes
• on persons allergic to iodine

Stop use and ask a doctor if

• skin shows symptoms of irritation, sensitivity, redness, pain or swelling. If condition persists for more than 72 hours consult a doctor.
• 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: clean under nails with a nail pick. Nails should be maintained with a 1 millimeter free edge; wet hands and forearms; scrub for 3 minutes with about 5 ml of scrub and a wet brush; pay particular attention to the nails, cuticles, and interdigital spaces; rinse and repeat
• Patient Preoperative Prep: clean the area; apply solution saturated sponge; starting at the surgical site moving outward in concentric circles for a minimum of 5 minutes; blot with sterile towel; follow with application of topical solution
• Antiseptic Handwash: wet hands and forearms; apply ample amount of solution to wet hands: wash in vigorous manner for 15 seconds; rinse and repeat

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?

Call: 1-800-523-0502 Mon.-Fri. 8 AM-5 PM CST

Package/Label Principal Display Panel

NDA 50425-010-98

Cat. 29904-004

Scrub Care® 7.5%

Povidone-iodine, Scrub

Antiseptic

Non-sterile Solution

7.5% Povidone-iodine, USP

For preparation of skin prior to surgery.

Helps reduce bacteria that potentially can cause skin infection.

For Single Use Only

Manufactured for

CareFusion

Vernon Hills, IL 60061 USA

51-10108

Net Contents: 4 fl. oz. (118 ml)

CareFusion

INGREDIENTS AND APPEARANCE

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

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; Type 0: Not a Combination Product	01/19/2015
2	NDC: 50425-010-98	118 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2015
3	NDC: 50425-010-97	236 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2015
4	NDC: 50425-010-96	472 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2015
5	NDC: 50425-010-95	944 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2015
6	NDC: 50425-010-94	3785 mL in 1 BOTTLE; Type 0: Not a Combination Product	01/19/2015

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 2200 Inc (832696038)

Establishment
Name	Address	ID/FEI	Business Operations
Thatcher Company		041307356	manufacture(50425-010)

Establishment
Name	Address	ID/FEI	Business Operations
CareFusion 213 LLC		826496312	pack(50425-010)