XTRA-7 (PART A)- chlorine dioxide teat dip solution

XTRA-7 (PART A) by

Drug Labeling and Warnings

XTRA-7 (PART A) by is a Animal medication manufactured, distributed, or labeled by AgroChem Inc. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

XTRA-7 (PART A)

XTRA-7 (PART A)

TEAT DIP

WARNINGS AND PRECAUTIONS

WARNING 

AVOID FREEZING.

KEEP OUT OF DIRECT SUNLIGHT

CAUSES SERIOUS EYE IRRITATION.

KEEP OUT OF REACH OF CHILDREN.

FOR FARM AND INDUSTRIAL USE ONLY

.

PREVENTION:  Wash skin thoroughly after handling. Wear eye protection/ face protection.

FIRST AID / RESPONSE: 

IF IN EYES: Rinse cautiously with water for several minutes. Remove contact lenses, if present and easy to do. Continue rinsing. If eye irritation persists:  Get medical advice/ attention.            

STORAGE:  Store locked up.                                                       

DISPOSAL: Dispose of contents/ container to an approved waste disposal plant              

EMERGENCY TELEPHONE NUMBER (Chemtrec) 800-424-9300 CCN205494

ACTIVE INGREDIENT

INGREDIENTS:

Lactic Acid - 2.64%

Emollient Package - 14 %

INSTRUCTIONS FOR USE

XTRA-7 is a two-part Chlorine Dioxide teat dip that can be effectively used to reduce the spread of mastitis causing organisms. Recommended for pre and post milking applications.

Directions:

NOTE: MUST BE MIXED PRIOR TO USE. MIX PART A & PART B in equal parts.

CREATES CHLORINE DIOXIDE. Reaches minimum Chlorine Dioxide levels within 15 minutes of mixing. Will maintain minimum Chlorine Dioxide levels for up to 24 hours. It is recommended to replace with freshly mixed XTRA-7 after 24 hours.

Directions:

General Use

Use a teat dip cup to apply.  Clean dip cup just prior to use.

If cow’s teats are sore or chapped, consult a veterinarian before starting or continuing to use teat dip.

If transferred from this container to any other, make sure that the other container is thoroughly pre-cleaned and bears the proper container labeling for this product. 

If product in dip cup becomes visibly dirty, discard contents and replenish with undiluted product. Do not reuse or return any unused product to the original container.

Teat Sprays can also be foamed or sprayed using recommended equipment.

Pre Dipping Use

Perform forestripping and inspect teats for clinical mastitis.

Pre-wash teats thoroughly just prior milking with appropriate udder wash solution or pre-milking teat dip. Teats should then be dried with single-service towels

Just before each cow is milked, dip, foam, or spray, each teat full-length into the teat dip or foam cup containing product.

Allow product to stand for 30 seconds.

Wipe teats dry after dipping, using single-service towels to avoid contamination of milk.

Post Dipping Use

Immediately after each milking, use product.

Dip each teat full-length into the teat dip cup containing product.  Allow to air dry.  Do not wipe.

If outside temperature is below freezing, allow to air dry on the teat before cow leaves the parlor.

Extended Use

When a cow is being dried off, the teats should be dipped in product, once a day for 3-4 days after the last milking.

Dipping should be resumed at least twice daily one week before calving.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

XTRA-7 (PART A) 
chlorine dioxide teat dip solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17307-3600
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.03 kg  in 1 kg
DODECYLBENZENESULFONIC ACID (UNII: 60NSK897G9) (DODECYLBENZENESULFONIC ACID - UNII:60NSK897G9)	DODECYLBENZENESULFONIC ACID	0.01 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
COUMARIN (UNII: A4VZ22K1WT)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
LANOLIN (UNII: 7EV65EAW6H)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-3600-1	19 kg in 1 CONTAINER
2	NDC: 17307-3600-2	57 kg in 1 DRUM
3	NDC: 17307-3600-3	208 kg in 1 DRUM
4	NDC: 17307-3600-4	1040 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/14/2018

Labeler - AgroChem Inc (805427700)

Registrant - AgroChem Inc (805427700)

Establishment
Name	Address	ID/FEI	Business Operations
AgroChem Inc		805427700	api manufacture, manufacture