Label: PREP 8X RTU- lactic acid solution
- NDC Code(s): 17307-3008-1, 17307-3008-2, 17307-3008-3, 17307-3008-4
- Packager: AgroChem USA, LLC
- 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 November 21, 2023
If you are a consumer or patient please visit this version.
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- Official Label (Printer Friendly)
- DESCRIPTION
- WARNINGS
- KEEP OUT OF REACH OF CHILDREN
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WARNINGS AND PRECAUTIONS
AVOID FREEZING.
KEEP OUT OF DIRECT SUNLIGHT.
CAUSES SERIOUS EYE IRRITATION.
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 AND HANDLING
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- INACTIVE INGREDIENT
- SPL UNCLASSIFIED SECTION
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INSTRUCTIONS FOR USE
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.
This product 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 to 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.
Use PREP 8X RTU effectively to reduce the spread of mastitis causing organisms. Recommended for pre milking applications.
- SPL UNCLASSIFIED SECTION
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
PREP 8X RTU
lactic acid solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:17307-3008 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength LACTIC ACID (UNII: 33X04XA5AT) (LACTIC ACID - UNII:33X04XA5AT) LACTIC ACID 0.023 kg in 1 kg Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:17307-3008-1 19 kg in 1 CONTAINER 2 NDC:17307-3008-2 57 kg in 1 DRUM 3 NDC:17307-3008-3 208 kg in 1 DRUM 4 NDC:17307-3008-4 1041 kg in 1 CONTAINER Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 09/13/2023 Labeler - AgroChem USA, LLC (118336116) Registrant - AgroChem USA, LLC (118336116) Establishment Name Address ID/FEI Business Operations AgroChem USA, LLC 118336116 api manufacture, manufacture, analysis, label, pack
