Label: AURA BARRIER- glyceryl laurate and lactic acid solution
- NDC Code(s): 17307-3934-1, 17307-3934-2, 17307-3934-3, 17307-3934-4
- Packager: AgroChem Inc
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Drug Label Information
Updated February 9, 2018
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- Official Label (Printer Friendly)
- DESCRIPTION
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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
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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
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INGREDIENTS AND APPEARANCE
AURA BARRIER
glyceryl laurate and lactic acid solutionProduct 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