PRO-TEC GOLD POVIDONE IODINE 10%- povidone-iodine solution

PRO-TEC GOLD by

Drug Labeling and Warnings

PRO-TEC GOLD by is a Animal medication manufactured, distributed, or labeled by Aurora Pharmaceutical, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS

Kills gram-negative and gram-positive bacteria, fungi, viruses, protozoa and yeasts. Film-forming, virtually non-irritating and non-staining to skin, hair and natural fabrics.

ACTIVE INGREDIENT

Povidone iodine 10% w/v Solution is equivalent to 1.0% titratable iodine.

DIRECTIONS FOR USE

Apply full-strength as often as needed. Wet area thoroughly to ensure complete coverage and penetration but avoid pooling. May be covered with bandage if necessary.

WARNINGS

Avoid contact with eyes. May be harmful if swallowed. If infection or irritation persists, discontinue use and consult a veterinarian.

KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN

STORAGE

Store at 20°–25° C (68°–77° F). Excursions permitted between 15°–30° C (59°–86° F). Keep container tightly closed when not in use.

OTHER SAFETY INFORMATION

SPL UNCLASSIFIED SECTION

REORDER NO: 59012

MANUFACTURED BY:
Aurora Pharmaceutical, LLC
NORTHFIELD, MINNESOTA 55057
888-215-1256
www.aurorapharmaceutical.com

IN 50-1198 REV 00

MANUFACTURED IN THE USA

PRINCIPAL DISPLAY PANEL - 1 Gallon Bottle Label

NDC: 51072-063-01

PRO-TEC GOLDTM

Povidone Iodine 10% Solution

Non-Irritating, Non-Staining Antiseptic Microbicide

For External Use Only

For Animal Use Only

1 Gallon (3.79 L)

aurora pharmaceutical ®

INGREDIENTS AND APPEARANCE

PRO-TEC GOLD  POVIDONE IODINE 10%
povidone-iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 51072-063
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	1.0 g  in 100 mL

Product Characteristics
Color	brown	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51072-063-01	3790 mL in 1 BOTTLE
2	NDC: 51072-063-00	946 mL in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/26/2012	04/30/2020

Labeler - Aurora Pharmaceutical, Inc. (832848639)

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