EDX-1000- iodine solution

EDX-1000 by

Drug Labeling and Warnings

EDX-1000 by is a Animal medication manufactured, distributed, or labeled by ProActive Solutions USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

EDX-1000

EDX-1000™ is a sanitizing iodine teat dip to aid in the prevention of the spread of
mastitis causing organisms.

Use instructions:

Use full strength.

Pre-Dipping: Just before milking, make sure the teats are clean and dry. Dip
each teat in undiluted EDX-1000™. Allow 5-30 seconds of contact time. Dry with a
single service towel and attach milker units.

Post-Dipping: Immediately after removing inflations, dip each teat in undiluted                                                    EDX-1000™. Allow teat to air dry. Do not wipe.

Replace the solution if it becomes visibly dirty.

Caution:

Hazard statement(s):
May be harmful if swallowed. May cause eye irritation.
Precautionary statement(s):
Do not eat, drink or smoke while using this product. Wear protective clothing, and eye and
face protection.
Hazards not otherwise classified: None Known

First Aid:

General Advice: May cause eye irritation with corneal injury and result in impairment of
vision.
External: If irritation occurs, flush with plenty of cool, running water for at least 15 minutes
while removing contaminated clothing and shoes. Wash clothing before reuse.
Eyes: Immediately flush with plenty of cool, running water. Remove contact lenses; then
continue flushing for at least 15 minutes, holding eyelids apart.
Internal: Call a physician immediately. If swallowed, do not induce vomiting. Rinse mouth,
then immediately drink one or two large glasses of water or milk. Never give anything by
mouth to an unconscious person.
Inhalation of vapors: Should not occur with proper use of this product.
Most important symptoms/effects, acute and delayed: None known
Immediate medical attention and special treatment needed, if any: None known

EDX-1000

INGREDIENTS AND APPEARANCE

EDX-1000 
iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 63927-4160
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	1 kg  in 100 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63927-4160-1	58.39 kg in 1 DRUM
2	NDC: 63927-4160-2	214.10 kg in 1 DRUM
3	NDC: 63927-4160-3	1070.48 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK
4	NDC: 63927-4160-4	1284.58 kg in 1 CONTAINER, FLEXIBLE INTERMEDIATE BULK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		01/21/2010

Labeler - ProActive Solutions USA, LLC (029368225)

Registrant - ProActive Solutions USA, LLC (029368225)

Establishment
Name	Address	ID/FEI	Business Operations
ProActive Solutions USA, LLC		029368225	api manufacture, manufacture, pack, relabel