4XLA ACTIVATOR- lactic acid liquid 
IBA

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

----------

4XLA ACTIVATOR

GERMICIDAL PRE-MILKING TREATMENTAn aid in reducing the spread of organisms which may cause mastitis.FOR USE ONLY WITH 4XLA BASE

image description

CAUTION: For external use only. Not for use in sanitizing dairy equipment. Do not mix with any other teat dip or other product. Avoid contact with food. Store at room temperature. Protect from heat and freezing. Always store away from continuous artificial light or direct sunlight. Avoid contact with eyes. If contact occurs, flush eyes with large quantities of water. See a physician if irritation develops.

ACTIVE INGREDIENT: 2.5% Lactic Acid


CONTAINS: Glycerin

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

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 throughout. 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 OFF. 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. 4XLA Teat Dip maybe diluted with water and safely flushed down the drain.

Note1: If teat irritation occurs, discontinue use until irritation subsides. Consult your veterinarian and milking equipment service personnel if irritation persists.
Note 2:AVOIDFREEZING. However, freezing will not affect this product provided that the contents are thawed completely and agitated thoroughly before mixing base and activator together.
Note 3: The gold color in the mixed product fades with time. At higher temperatures he fading is more rapid. However this will not affect the efficacy of the product.
Note 4: 4XLA should be used only with a compatible pre-dip or udder wash.


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

KEEP OUT OF REACH OF CHILDREN
NOT FOR HUMAN USE
ALWAYS SEEK IMMEDIATE MEDICAL ATTENTION
FOR MEDICAL EMERGENCIES CALL 1-800-424-9300

READ THIS NOTICE
Ecolab Inc. and IBA's liability on any claim, whether in negligence or in any tort or in contract or otherwise, with respect to products delivered hereunder, shall not exceed the purchase price of the products sold or, if Ecolab Inc. and IBA shall so elect, buyer shall be entitled only to a replacement of the product. In no event shall Ecolab Inc. and IBA be liable for buyers’ incidental or consequential damages.

4XLA ACTIVATOR 
lactic acid liquid
Product Information
Product Type OTC ANIMAL DRUG Item Code (Source) NDC:29983-1032
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 2.5 kg  in 100 kg
Inactive Ingredients
Ingredient Name Strength
GLYCERIN (UNII: PDC6A3C0OX)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:29983-1032-4 19.39 kg in 1 PAIL
2 NDC:29983-1032-6 58.17 kg in 1 DRUM
3 NDC:29983-1032-8 213.30 kg in 1 DRUM
4 NDC:29983-1032-9 1066.503 kg in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/29/2015
Labeler - IBA (019494160)
Establishment
Name Address ID/FEI Business Operations
Morgan Gallacher Inc. DBA in Custom Chemical Formulators Inc. 028311595 manufacture, api manufacture, pack

Revised: 6/2015
Document Id: 418c667c-ab6e-4735-ad6a-5ead309f79d0
Set id: f93303bd-451c-4fd3-99d7-370e2eb444e9
Version: 1
Effective Time: 20150629
 
IBA