UDDERGOLD 5-STAR ACTIVATOR (alpha-hydroxy acids- mixture of lactic acid and mandelic acid solution

Uddergold 5-Star Activator by

Drug Labeling and Warnings

Uddergold 5-Star Activator by is a Animal medication manufactured, distributed, or labeled by Ecolab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAFE HANDLING WARNING

FOR USE ONLY WITH UDDERgold  5-STAR BASE

ATTENTION: For External Use Only. Wash hands thoroughly after handling. Get medical advice/ attention if you feel unwell.

KEEP OUT OF THE REACH OF CHILDREN

NOT FOR HUMAN USE

VETERINARY INDICATIONS

Mixing Directions: Add equal volumes of Activator and Base into a clean dip cup/container and mix until the color is uniform throughout. Do not dilute. Mix only amount needed for one milking of the herd. The average amount of product used is less than 1/4 ounce per cow per milking. Discard any unused teat dip. If product in dip cup becomes visibly dirty, discard contents and fill with fresh teat dip. Do not mix with any other product.

APPLICATION: Before milking, pre-dip or wash teats thoroughly with compatible pre-dip or udder wash. Immediately after milking, dip teats to 2/3 length in UDDERgold®5-STAR. Allow to dry. Do not wipe. Do not turn cows out in freezing weather until teat dip is completely dry.

Note 1: If teat irritation occurs, discontinue use until irritation subsides. Consult your veterinarian if irritation persists.

Note 2: The gold color in the mixed product fades with time and is more rapid at higher temperatures. This will not affect the efficacy of the product.

Note 3:Avoid Freezing. However, freezing will not affect the performance of this product provided that the frozen contents are thawed completely and agitated thoroughly before mixing Base and Activator together.

OTHER SAFETY INFORMATION

STORAGE: Store at room temperature. Protect from freezing and heat. Always store away from continuous artificial light or direct sunlight. If product is exposed to freezing temperatures, Activator and Base must be agitated thoroughly prior to mixing.

DISPOSAL:  Dilute unused teat dip and flush down drain with water. Do not reuse containers. Empty containers should be thoroughly rinsed with water and taken to a recycling center.

PRINCIPAL DISPLAY PANEL

UDDERgold 5-STAR

GERMICIDAL BARRIER TEAT DIP

An aid in reducing the spread of organisms which may cause mastitis.

Provides protective gel barrier over teat end until next milking. Contains an emollient system

ACTIVATOR

ACTIVE INGREDIENTS:

Alpha-Hydroxy Acids............................................1.7%

(Mixture of Lactic Acid and Mandelic Acid.)

INERT INGREDIENTS: ......................................92.3%

SKIN CONDITIONING SYSTEM:

(contains glycerin, PEG-75 lanolin) ................. 6.0%

TOTAL: .............................................................100.0%

Teat Dip

Distributed by:

Ecolab

1 Ecolab Place

St. Paul, Minnesota  55102 U.S.A.

UDDERgold® is a registered trademark of Ecolab Inc. St. Paul, MN 55102

Made in USA

U.S. Patent No. 4,891,216 USRE37263   US 6,524,624

Patents Pending

6301988

208 L (55 US GAL)

766668/5300/0916

INGREDIENTS AND APPEARANCE

UDDERGOLD 5-STAR ACTIVATOR 
alpha-hydroxy acids (mixture of lactic acid and mandelic acid) solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 47593-609
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	15 mg  in 1 mL
MANDELIC ACID (UNII: NH496X0UJX) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	3 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
PEG-75 LANOLIN (UNII: 09179OX7TB)
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47593-609-16	18900 mL in 1 PAIL
2	NDC: 47593-609-17	56800 mL in 1 DRUM
3	NDC: 47593-609-21	208000 mL in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		11/29/2005

Labeler - Ecolab Inc. (006154611)

Establishment
Name	Address	ID/FEI	Business Operations
Ecolab Inc.		943879395	manufacture, api manufacture, analysis, pack, repack, label, relabel