PREVAIL- a sanitizing npe free non-iodine teat dip liquid

PREVAIL by

Drug Labeling and Warnings

PREVAIL 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:

Hydrogen Peroxide..........................................................1.00%

Lactic Acid......................................................................0.50%

INERT INGREDIENTS:

Glycerin (As A humectant and Skin Conditioner).................5.00%

Other Inerts................................................................93.50%

(Includes Buffering Agents, Stabilizing Agents, Wetting Agents

and Colorants)

TOTAL...................................................................... ..100.00%

GENERAL PRECAUTIONS

GENERAL RECOMMENDATION

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. AVOID CONTACT WITH FOOD.

DO NOT TAKE INTERNALLY. PROTECT EYES AND MUCOUS MEMBRANES

 FROM CONTACT WITH THIS PRODUCT.

FIRST AID PROCEDURES

EYE CONTACT: 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 IRRIGATION 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 foremilk by stripping two or three streams of milk into a strip cup.

3. Dip, foam or spray the cow's teats full length with PREVAIL Teat Dip.

4. Wait approximately 30 seconds.

5. Remove all teat dip by thoroughly drying the teats, teat orifices and udder (if foaming or spraying) with a clean, single, service paper towerl(s) to avoid contamination of milk.

6. Attach milking unit.

B. POST-MILKING (POST-DIPPING)

1. Immediately after milking, dip or spray all teats full length with PREVAIL Teat Dip. Ensure good coverage of all sides of the teats and teat orifices.

WARNING

DO NOT MIX PREVAIL 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.

                          Not For Human Use

PREVAIL

PREVAIL

INGREDIENTS AND APPEARANCE

PREVAIL 
a sanitizing npe free non-iodine teat dip liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 29983-1075
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROGEN PEROXIDE (UNII: BBX060AN9V) (HYDROGEN PEROXIDE - UNII:BBX060AN9V)	HYDROGEN PEROXIDE	.60 kg  in 100 kg
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	.50 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: 29983-1075-4	19.28 kg in 1 CONTAINER
2	NDC: 29983-1075-6	57.83 kg in 1 CONTAINER
3	NDC: 29983-1075-8	212.06 kg in 1 DRUM
4	NDC: 29983-1075-9	1060.29 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/16/2019

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