ASSURE-M by IBA / Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc. ASSURE-M- n/a liquid

ASSURE-M by

Drug Labeling and Warnings

ASSURE-M by is a Animal medication manufactured, distributed, or labeled by IBA, Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENTS

Active Hydrogen Peroxide...........0.60%
Lactic Acid……………………….…………0.70%
Benzoic Acid...............................0.20%

INERT INGREDIENTS

Glycerin..........................................6.00%
Other Inerts:................................92.50%
(includes Buffering Agents, Stabilizing Agents, Wetting Agents and Colorants)
TOTAL.................100%

GENERAL RECOMMENDATIONS

1. Use teat dip applicators made of plastic or other non-corrosive materials. Do not use cups made of aluminum.
2. When solution in the teat dip cup becomes visibly dirty, discard remaining contents and refill cup with fresh teat dip.
3. Do not use this product for cleaning or sanitizing equipment.
4. Wash Teat Dip cups after each milking.

CAUTION

KEEP OUT OF REACH OF CHILDREN

FOOD SAFETY WARNING

AVOID CONTACT WITH FOOD. DO NOT TAKE INTERNALLY.

PROTECT EYES AND MUCOUS MEMBRANES FROM CONTACT WITH THIS PRODUCT. FIRST AID PROCEDURES

EYE CONTACT: IMMEDIATELY FLUSH EYE WITH LARGE AMOUNTS OF FRESH, TEPID WATER FOR 15 MINUTES. HOLD EYELID OPEN TO ENSURE COMPLETE IRRIGATION OF EYE AND LID TISSUES. TILT HEAD TO THE SIDE AND IRRIGATE THE EYE FROM THE BRIDGE OF THE NOSE TO THE OUTSIDE OF THE FACE. IF IRRITAITION DEVELOPS CONSULT A PHYSICIAN.
SKIN CONTACT: WASH ANY SENSITIVE AREAS.
INGESTION: DRINK TWO GLASSES OF WATER AND CONSULT A PHYSICIAN
ALWAYS SEEK IMMEDIATE MEDICAL ATTENTION
FOR MEDICAL EMERGENCIES CALL 1-800-424-9300

RECOMMENDED PROCEDURES FOR TEAT SANITATION:

A. PRE-MILKING (PRE-DIPPING)
1. Remove visible soils from the teats.
2. Observe formilk by stripping two or three streams of milk into a strip cup.
3. Dip or spray the cow's teats full length with ASSURE-M Teat Dip.
4. Wait approximately 30 seconds.
5. Remove all teat dip by thoroughly drying the teats and teat orifices and udder (if foaming or spraying) with a clean, single service paper towels(s).
6. Attach milking unit.
B. POST-MILKING (POST-DIPPING)
1. Immediately after milking, dip or spray all teats full length with ASSURE-M Teat Dip. Ensure good coverage of all sides of the teats and teat orifices.
A PART OF THE COMPLETE IBA SANITATION PROGRAM

WARNINGS

WARNING
DO NOT MIX ASSURE-M WITH ANY OTHER PRODUCT.
DO NOT DILUTE PRODUCT.
DO NOT RETURN TEAT DIP LEFT IN THE TEAT DIPPER TO STORAGE CONTAINER.
ENSURE THAT DIPPED OR SPRAYED TEATS ARE DRY BEFORE EXPOSING THE ANIMALS TO WEATHER CONDITIONS WHICH MAY CAUSE DAMAGE TO THE TEATS.

PROTECT THIS PRODUCT FROM FREEZING.

ASSURE-M SANITIZING TEAT DIP A HIGHLY EFFECTIVE PRE-MILKING AND POST-MILKING TEAT DIP WITH GLYCERIN CONTAINS THREE GERMICIDES AND GLYCERIN AS A HUMECTANT AND SKIN CONDITIONER

Assure M

INGREDIENTS AND APPEARANCE

ASSURE-M 
n/a liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 29983-1064
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.60 kg  in 100 kg
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.70 kg  in 100 kg
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	0.20 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: 29983-1064-4	19.28 kg in 1 PAIL
2	NDC: 29983-1064-6	57.83 kg in 1 DRUM
3	NDC: 29983-1064-8	212.05 kg in 1 DRUM
4	NDC: 29983-1064-9	1060.27 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/09/2016

Labeler - IBA (019494160)

Registrant - IBA (019494160)

Establishment
Name	Address	ID/FEI	Business Operations
Morgan Gallacher Inc. DBA Custom Chemical Formulators Inc.		028311595	manufacture, api manufacture, pack