UDDER 330- iodine solution

Udder 330 by

Drug Labeling and Warnings

Udder 330 by is a Animal medication manufactured, distributed, or labeled by ProActive Solutions USA, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

UDDER 330

Udder 330™ is a sanitizing iodine product that provides germicidal activity in the prevention of mastitis. It contains wetting agents to help penetrate soils to get teats clean prior to attaching the milking units. Udder 330™ contains skin emollients to aid in improving the skin condition of the teats.

USE INSTRUCTIONS:

Udder Washing: Prepare a fresh solution of Udder 330™ by adding 1 oz to 1.5                                                           gallons of 110 F water. (This provides 25 ppm titratable iodine).

Using a clean single service towel, wash and massage the cow’s teats and udder area.

Wipe dry.

Apply the milker unit about one minute after washing.

Do not reuse towels or dip a used towel back into the solution.

Make up a fresh solution daily or when the use solution becomes visibly dirty.

Keep from freezing. If frozen, thaw completely and shake well before using.

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:

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

UDDER 330

INGREDIENTS AND APPEARANCE

UDDER 330 
iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 63927-4442
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	0.5 kg  in 100 kg

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 63927-4442-1	15.40 kg in 1 CASE
2	NDC: 63927-4442-2	19.26 kg in 1 JUG
3	NDC: 63927-4442-3	57.77 kg in 1 DRUM
4	NDC: 63927-4442-4	211.81 kg in 1 DRUM
5	NDC: 63927-4442-5	1059.04 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		10/29/2007

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, label, repack