4XLA ACTIVATOR- lactic acid liquid

4XLA ACTIVATOR by

Drug Labeling and Warnings

4XLA ACTIVATOR by is a Animal medication manufactured, distributed, or labeled by IBA, Morgan Gallacher Inc. DBA in Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

ACTIVE INGREDIENT: 2.5% Lactic Acid

CONTAINS: Glycerin

GENERAL PRECAUTIONS

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.

DISPOSAL AND WASTE HANDLING

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

INDICATIONS & USAGE

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

OTHER SAFETY INFORMATION

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

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

4XLA Activator

INGREDIENTS AND APPEARANCE

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