DEFEND II- iodine liquid

Defend II by

Drug Labeling and Warnings

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

Drug Details [pdf]

Defend II

Defend II™ is a 1% sanitizing iodine barrier dip with a 10% skin
conditioning package which is very economical in its usage. Defend II™ provides
extended protection against mastitis-causing organisms in challenging conditions
such as exposure to mud, manure and alternative bedding materials. Tests show that
unlike regular teat dips and sprays, more than one-third of the Defend II™ barrier dip
remains on the teats 20 minutes after application.

Use Instructions:

Post-Dipping/Spraying: Dip/spray teats with undiluted product immediately after
milking. Allow to air dry.
Freshening Cows: Begin dipping teats twice daily for about 10 days before calving.
Dry Cows: Dip/spray teats once a day for several days following the last milking.
Cold Weather: Do not turn out cows until teats are dry to prevent chapping
and freezing. If necessary, wipe dry with a single service towel.

Do not use this product for cleaning or sanitizing equipment.

Replace the solution if it becomes visibly dirty.

Teat Irritation or Chapping: Teat dips have the potential to cause irritation of a
cow’s teats or milker’s hands. Individual tolerance to a particular formulation as well
as other factors (dry or cold weather, improper teat dip application, bedding quality,
milking equipment, etc.) may also affect teat condition. If you observe abnormal
irritation or chapping, discontinue use and contact your sales representative or call
your dealer.

Disposal Considerations:
Disposing of contaminated packaging: To clean the container before final disposal,
empty the remaining contents from this container into application equipment. Fill
the container ¼ full with water. Replace and tighten closures. Agitate vigorously or
recirculate water for 30 seconds. Empty the rinsate into application equipment or a
mix tank or store rinsate for later use or disposal. Repeat this procedure two more
times.

Caution:

Hazard statement(s):
May be harmful if swallowed. Causes 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

Defend II

INGREDIENTS AND APPEARANCE

DEFEND II 
iodine liquid

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 63927-4121
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: 63927-4121-1	15.31 kg in 1 CASE
2	NDC: 63927-4121-2	19.14 kg in 1 JUG
3	NDC: 63927-4121-3	57.43 kg in 1 DRUM
4	NDC: 63927-4121-4	210.56 kg in 1 DRUM
5	NDC: 63927-4121-5	1052.80 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		07/17/2009

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, repack, label