4XLA- lactic acid solution

4XLA by

Drug Labeling and Warnings

4XLA by is a Animal medication manufactured, distributed, or labeled by Ecolab Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SAFE HANDLING WARNING

NOT FOR HUMAN USE

FOR USE ONLY WITH 4XLA® BASE

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

VETERINARY INDICATIONS

DIRECTIONS FOR USE: Measure equal

volumes of 4XLA® base and 4XLA

activator into a clean dip cup/containe r

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

Not for use in sanitizing dairy equipment. Do notmix with any other teat dip or other product. Avoidcontact with food. Store at room temperature.Protect from heat and freezing. Always store awayfrom continuous artificial light or direct sunlight.

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

KEEP OUT OF THE REACH OF CHILDREN

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

PRINCIPAL DISPLAY PANEL

SELECT SIRES INC. 6301911

4XLA®GERMICIDAL PRE- & POST-MILKING TEAT DIP

An aid in reducing the spread of organisms which may causemastitis

Contains an emollient system

ACTIVATOR

ACTIVE INGREDIENT:

Lactic Acid ...........................................................2.5%

INERT INGREDIENTS:.................................... 87.5%

SKIN CONDITIONING SYSTEM:

(contains glycerin) .......................................... 10.0%

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

Distributed by:

Select Sires, Inc.

11740 U.S. 42N P.O. Box 143

Plain City, OH 43064-0143

614-873-4683

www.selectsires.com

4XLA® is a registered trademark of

Ecolab Inc., St. Paul, MN 55102

Made in USA

Patent USRE37263

U.S. Patent 5,384,134

Foreign Patents Issued and Pending

18.9 L (5 US GAL)

INGREDIENTS AND APPEARANCE

4XLA 
lactic acid solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 47593-424
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 47593-424-16	18900 mL in 1 PAIL
2	NDC: 47593-424-17	56800 mL in 1 DRUM
3	NDC: 47593-424-21	208200 mL in 1 DRUM
4	NDC: 47593-424-44	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)