Gentle Iodine 1%: Product Information

GENTLE IODINE 1%- iodine solution
Aspen Veterinary Resources Ltd

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.

Topical Antiseptic
For animal use only.
Keep out of reach of children.

INDICATIONS
In horses, cattle, swine and sheep as a topical antiseptic for use prior to surgical procedures such as castrating and docking; for ringworm and foot rot; for application to the navel of newborn animals; and for the aid in the treatment of minor cuts, teat sores, bruises, and abrasions

DIRECTIONS
Remove spray cap from 16 oz. container and refill from gallon container. Replace spray cap tightly. Hold container approxiamately 4 to 6 inches from the area to be sprayed. Pull trigger of valve and spray area once lightly. May be repeated daily, when necessary, until abraded area is healed.

CAUTION
If redness, irritation, or swelling persists or increases discontinue use and consult a veterinarian. Not for use on burns or in body cavities or deep wounds.

NOTE
When used on or near the teats or udders of dairy animals, the teats and udders should be thoroughly washed before the next milking to prevent contamination of milk.

Active Ingredients
1% titratable Iodine
Inactive Ingredients
Water & Nonionic Surfactant

CAUTION
Harmful or fatal if swallowed. Do not apply to the eyes, mucous membranes or large areas of abraded skin. Avoi inhalation of mist.

KEEP TIGHTLY CLOSED WHEN NOT IN USE.
FOR EXTERNAL ANIMAL USE ONLY.
KEEP OUT REACH OF CHILDREN. STORE AT 10o-29oC (50o-85oF)

GENTLE IODINE 1% iodine solution

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-031 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 0.01 mg in 1 mL

Inactive Ingredients Ingredient Name Strength WATER 0.99 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:46066-031-91 473 mL in 1 BOTTLE None 2 NDC:46066-031-93 3785 mL in 1 JUG None

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 01/01/2015

Labeler — Aspen Veterinary Resources Ltd (627265361)

Establishment
Name	Address	ID/FEI	Operations
Centaur Inc		174239087	api manufacture, manufacture

Revised: 09/2017 Aspen Veterinary Resources Ltd