SURGICAL SCRUB POVIDONE IODINE- iodine solution

Surgical Scrub by

Drug Labeling and Warnings

Surgical Scrub by is a Animal medication manufactured, distributed, or labeled by Aurora Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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DRUG FACTS

DESCRIPTION

• ACTIVE INGREDIENT: PURPOSE
• Povidone Iodine, 7.5% (0.75% available iodine): Antiseptic

USES

• For preparation of the skin prior to surgery.
• Helps to reduce bacteria that potentially can cause skin infection.
• For hand washing to reduce bacteria on the skin.
• Significantly reduces the number of microorganisms on the hands and forearms prior to surgery or patient care.

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KEEP OUT OF REACH OF CHILDREN

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

STORAGE AND HANDLING

Store at 20°– 25° C (68°– 77° F). Excursions permitted between 15°– 30° C (59°– 86° F).
Store in original container.

DIRECTIONS

Surgical hand scrub:

• Wet hands with water.
• Spread about 5 mL (1 teaspoonful) of scrub over both hands and forearms.
• Without adding more water, scrub thoroughly for 2½ –3 minutes.
• Use a sponge, if desired. Clean thoroughly under fingernails.
• Add a little water and develop copious suds. Rinse thoroughly under running water.
• Repeat entire procedure using another 5 mL of scrub.

Antiseptic hand wash:

• Wet hands with water and pour about 5 mL of scrub on hands.
• Rub hands vigorously together for at least 15 seconds, covering all surfaces.
• Rinse and dry with a disposable towel.

Preoperative skin preparation:

• After the surgical area is clipped, wet it with water.
• Apply scrub (1 mL is sufficient to cover an area of 20–30 square inches), develop lather, and scrub thoroughly for about 5 minutes.
• Rinse using sterile gauze saturated with water.
• The area may then be painted with PRO-TEC GOLD Surgical Scrub and allowed to dry.

WARNINGS

For external use only. Do not use this product in the eyes or on food-producing animals.

When using this product, prolonged exposure to wet solution may cause irritation or, rarely, severe skin reactions. In preoperative prepping, avoid "pooling" beneath the animal.

Stop use and ask a doctor or veterinarian if irritation and redness develops or in rare instances of local irritation or sensitivity.

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MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com
IN 50-1199     REV 00

REORDER
NO: 59014

MANUFACTURED IN THE USA

PRINCIPAL DISPLAY PANEL - 3.79 L Bottle Label

NDC: 51072-064-01

PRO-TEC GOLD™

Surgical Scrub

Povidone Iodine 7.5%

Antiseptic Sudsing Skin Cleanser

For External Use Only

1 Gallon (3.79 L)

aurora
PHARMACEUTICAL®

INGREDIENTS AND APPEARANCE

SURGICAL SCRUB   POVIDONE IODINE
iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51072-064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	7.5 g  in 100 mL

Inactive Ingredients
Ingredient Name	Strength
water (UNII: 059QF0KO0R)
sodium phosphate, dibasic, anhydrous (UNII: 22ADO53M6F)
anhydrous citric acid (UNII: XF417D3PSL)
glycerin (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-064-01	3790 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		01/29/2013	04/30/2020

Labeler - Aurora Pharmaceutical, Inc. (832848639)

Establishment
Name	Address	ID/FEI	Business Operations
Aurora Pharmaceutical, Inc.		832848639	MANUFACTURE