ASSURE- hydrogen peroxide liquid

ASSURE by

Drug Labeling and Warnings

ASSURE by is a Animal medication manufactured, distributed, or labeled by IBA, Morgan Gallacher Inc. DBA Custom Chemical Formulators. 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......................92.5%
(Includes buffering agents, stabilizing agents, wetting agents
and colorants)
TOTAL............................100.00%

INDICATIONS AND USAGE

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.
RECOMMENDED PROCEDURES FOR TEAT SANITATION
A. PRE-MILKING (PRE-DIPPING)
1. REMOVE VISIBLE SOILS FROM THE TEATS.
2. OBSERVE FOREMILK BY STRIPPING TWO OR THREE STREAMS OF MILK INTO A STRIP CUP.
3. DIP OR SPRAY THE COW'S TEATS FULL LENGTH WITH ASSURE TEAT DIP.
4. WAIT APPROXIMATELY 30 SECONDS.
5. REMOVE ALL TEAT DIP BY THOROUGHLY DRYING THE TEATS AND TEAT ORIFICES AND UDDER (IF SPRAYING), WITH A CLEAN, SINGLE SERVICE PAPER TOWEL(S) TO AVOID CONTAMINATION OF MILK.
6. ATTACH MILKING UNIT.
B. POST-MILKING (POST-DIPPING)
Immediately after milking, dip or spray all teats full length with ASSURE Teat Dip. Ensure good coverage of all sides of the teats and teat orifices.

A PART OF THE COMPLETE IBA SANITATION PROGRAM

WARNING

DO NOT MIX ASSURE TEAT DIP WITH ANY OTHER PRODUCT.
DO NOT DILUTE THIS PRODUCT.
DO NOT RETURN TEAT DIP LEFT IN THE TEAT DIPPER TO STORAGE CONTAINER.
ENSURE THAT DIPPED TEATS ARE DRY BEFORE EXPOSING THE ANIMALS TO WEATHER CONDITIONS WHICH MAY CAUSE DAMAGE TO THE TEATS.
PROTECT THIS PRODUCT FROM FREEZING.

CAUTION: KEEP OUT OF REACH OF CHILDREN.
AVOID CONTACT WITH FOOD. DO NOT TAKE INTERNALLY.

FIRST AID PROCEDURES

EYECONTACT: AVOID CONTACT WITH EYES. IF CONTACT OCCURS, FLUSH EYE WITH LARGE QUANTITIES OF FRESH, TEPID WATER FOR 15 MINUTES. HOLD EYELID OPEN TO ENSURE COMPLETE IRRIGATION OF EYE AND LID TISSUE. TILT HEAD TO THE SIDE AND IRRIGATE THE EYE FROM THE BRIDGE OF THE NOSE TO THE OUTSIDE OF THE FACE. IF IRRITATION DEVELOPS, CONSULT A PHYSICIAN.

SKIN CONTACT: FOR READY TO USE PRODUCTS, 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

Assure

Assure

INGREDIENTS AND APPEARANCE

ASSURE 
hydrogen peroxide liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 29983-1023
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	0.6 kg  in 100 kg
BENZOIC ACID (UNII: 8SKN0B0MIM) (BENZOIC ACID - UNII:8SKN0B0MIM)	BENZOIC ACID	0.2 kg  in 100 kg
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	.7 kg  in 100 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 29983-1023-4	19.23 kg in 1 PAIL
2	NDC: 29983-1023-6	57.70 kg in 1 DRUM
3	NDC: 29983-1023-7	115.39 kg in 1 DRUM
4	NDC: 29983-1023-8	211.55 kg in 1 DRUM

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/09/2014

Labeler - IBA (019494160)

Registrant - IBA (019494160)

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