AURA BARRIER- glyceryl laurate and lactic acid solution

Aura Barrier by

Drug Labeling and Warnings

Aura Barrier by is a Animal medication manufactured, distributed, or labeled by AgroChem Inc, AgroChem Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

DESCRIPTION

AURA BARRIER DIP

TEAT DIP

WARNINGS

WARNING

CAUSES SERIOUS EYE IRRITATION.

FOR FARM AND INDUSTRIAL USE ONLY.

KEEP OUT OF REACH OF CHILDREN.

KEEP OUT OF DIRECT SUNLIGHT.

AVOID FREEZING.

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:

Active Ingredients:

    Glycerol Monolaurate - 1%

     Lactic Acid - 3%

     Emollients - 7.5%

INSTRUCTIONS FOR USE

Use Aura Barrier Dip effectively to reduce the spread of mastitis causing organisms.   The specially selected emollients in Aura Barrier Dip soften teat skin and protect the surface of the teat by keeping it moistened and smooth. Aura Barrier Dip is suitable for use as a pre or post dip. 

Directions:

General Use

Ready to use.  Do not dilute.  Do not mix product with water, any other teat dips, or other product.

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

AURA BARRIER 
glyceryl laurate and lactic acid solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 17307-3934
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
GLYCERYL LAURATE (UNII: Y98611C087) (GLYCERYL LAURATE - UNII:Y98611C087)	GLYCERYL LAURATE	0.0025 kg  in 1 kg
LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT)	LACTIC ACID	0.03 kg  in 1 kg

Inactive Ingredients
Ingredient Name	Strength
LANOLIN (UNII: 7EV65EAW6H)	0.0025 kg  in 1 kg
GLYCERIN (UNII: PDC6A3C0OX)	0.04 kg  in 1 kg
POLYSORBATE 20 (UNII: 7T1F30V5YH)	0.03 kg  in 1 kg
C10-16 PARETH-1 (UNII: 3Y76363WPB)	0.003 kg  in 1 kg
C9-11 PARETH-3 (UNII: 8O4974OMUO)	0.003 kg  in 1 kg
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)	0.035 kg  in 1 kg
XANTHAN GUM (UNII: TTV12P4NEE)	0.0033 kg  in 1 kg
ALGINIC ACID (UNII: 8C3Z4148WZ)	0.0022 kg  in 1 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 17307-3934-1	19 kg in 1 CONTAINER
2	NDC: 17307-3934-2	57 kg in 1 DRUM
3	NDC: 17307-3934-3	208 kg in 1 DRUM
4	NDC: 17307-3934-4	1040 kg in 1 CONTAINER

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/01/2013

Labeler - AgroChem Inc (805427700)

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