4XLA BASE- sodium chlorite solution

4XLA Base by

Drug Labeling and Warnings

4XLA Base 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 4XLA® ACTIVATOR

DANGER: Causes severe skin burns and eye damage. Wash skin thoroughly after handling. Wear protective gloves/ protective clothing/ eye protection/ face protection.

DISPOSAL: Unused teat dip may be diluted with water and flushed down drain. Do not reuse containers. Empty containers should be thoroughly rinsed with water and taken to a recycling center.

KEEP OUT OF THE REACH OF CHILDREN

NOT FOR HUMAN USE

AVOID FREEZING: If product is exposed to freezing temperatures, components must be mixed thoroughly prior to use.

VETERINARY INDICATIONS

DIRECTIONS FOR USE: Measure equal volumes of 4XLA® base and 4XLA activator into a clean dip cup/container and mix until the color is uniform through-out. Do not dilute. Mix only enough product for one milking of the herd. Dip cups should be washed after each milking.

APPLICATION:

Pre-Milking: If teats are visibly dirty, wash and dry teats with a single service towel prior to dipping. Before each cow is milked, dip the teats as far up as possible. Leave 4XLA Teat Dip on teats for at least 15-30 seconds. Wipe teats dry using a single service towel before milking.

Post-Milking: Immediately after milking, dip teats at least 2/3 to all their length in 4XLA Teat Dip. Allow to air dry. DO NOT WIPE. 4XLA Teat Dip can be used as a post-dip alone, or as a pre- and post-milking teat dip.

Always use freshly mixed, full strength 4XLA Teat Dip. If product in dip cup becomes visibly dirty, discard contents and fill with fresh 4XLA Teat Dip.

Note 1: If teat irritation occurs, discontinue use until irritation subsides. Consult your veterinarian and milking equipment service personnel if irritation persists.

Note 2: The gold color in the mixed product fades with time. At higher temperatures the fading is more rapid. However, this will not affect the efficacy of the product.

Note 3: 4XLA should be used only with a compatible pre-dip or udder wash.

OTHER SAFETY INFORMATION

IF SWALLOWED: Rinse mouth. Do NOT induce vomiting. IF ON SKIN (or hair): Take off immediately all contaminated clothing. Rinse skin with water/ shower. IF INHALED: Remove person to fresh air and keep comfortable for breathing. Immediately call a POISON CENTER/ doctor. IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. Immediately call a POISON CENTER/ doctor. Wash contaminated clothing before reuse.

PRINCIPAL DISPLAY PANEL

SELECT SIRES

6301916

4XLA®

GERMICIDAL PRE- & POST-MILKING TEAT DIP

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

BASE

ACTIVE INGREDIENT:

Sodium Chlorite................................................... 0.6%

INERT INGREDIENTS:....................................... 99.4%

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

208 L (55 US GAL)

4XLA® is a registered trademark of

Ecolab Inc., St. Paul, MN 55102

Made in USA

U.S. Patent RE37263, U.S. Patent 5,384,134

Foreign Patents Issued and Pending

Distributed by:

Select Sires, Inc.

11740 U.S. 42N P.O. Box 143 Plain City, OH  43064-0143

614-873-4683

www.selectsires.com

INGREDIENTS AND APPEARANCE

4XLA BASE 
sodium chlorite solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 47593-607
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM CHLORITE (UNII: G538EBV4VF) (CHLORITE ION - UNII:Z63H374SB6)	SODIUM CHLORITE	6 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47593-607-16	18900 mL in 1 PAIL
2	NDC: 47593-607-17	56800 mL in 1 DRUM
3	NDC: 47593-607-21	208000 mL in 1 DRUM
4	NDC: 47593-607-44	1134000 mL in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/08/2014

Labeler - Ecolab Inc. (006154611)

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