WINTER DINE- iodine solution

Winter Dine by

Drug Labeling and Warnings

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

Drug Details [pdf]

Winter Dine

Winter Dine™ is a sanitizing iodine teat dip that is formulated with a 50% emollient system to enhance skin
conditioning during inclement weather.
This product, when properly used, is effective as an aid in reducing the spread of
organisms which may cause mastitis.

use instructions:

Use at full strength, do not dilute.

Post-Dipping: Dip entire teat. Allow to air dry.

Freshening Cows: Dip teats twice daily for 10 days before calving.

Dry cows: Dip once a day for several days following last milking.

Do not return unused product to original container.

Replace solution if it becomes visibly dirty or cloudy.

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

F irst Aid:

General Advice: May cause eye irritation with corneal injury and result in impairment ofvision.
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

Winter Dine

INGREDIENTS AND APPEARANCE

WINTER DINE 
iodine solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 63927-4460
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: 63927-4460-1	17.11 kg in 1 CASE
2	NDC: 63927-4460-2	21.39 kg in 1 JUG
3	NDC: 63927-4460-3	64.18 kg in 1 DRUM
4	NDC: 63927-4460-4	235.32 kg in 1 DRUM
5	NDC: 63927-4460-5	1176.60 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		04/13/2016

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