Label: GENTLE IODINE 1%- iodine solution
- NDC Code(s): 46066-031-91, 46066-031-93
- Packager: Aspen Veterinary Resources Ltd
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Drug Label Information
Updated September 5, 2017
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WARNINGS AND PRECAUTIONS
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) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
GENTLE IODINE 1%
iodine solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:46066-031 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE 0.01 mg in 1 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) 0.99 mg in 1 mL Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:46066-031-91 473 mL in 1 BOTTLE 2 NDC:46066-031-93 3785 mL in 1 JUG 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 Business Operations Centaur Inc 174239087 api manufacture, manufacture