Label: 1% IODINE WOUND- iodine solution
- NDC Code(s): 58305-027-16, 58305-027-80
- Packager: Centaur Inc
- Category: OTC ANIMAL DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Drug Label Information
Updated August 24, 2017
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WARNINGS AND PRECAUTIONS
Topical Antiseptic
For animal use only.
Keep out of reach of children.INDICATIONS
For use in horses, cattle, swine and sheep as a topical antiseptic for use prior to surgical procedures such as castrating and tail docking; for application to the umbilical stump (navel) of newborn animals; and for the aid in the treatment of minor cuts, bruises, teat sores, and abrasionsDIRECTIONS
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. Point valve at the area to be sprayed. Pull trigger and spray area once lightly. May be repeated daily, when necessary, until abraded area is healed. Apply to the umbilical stump of newborns 2-3 times per day until stump has dried.
When using prior to surgical procedures, allow 10 minutes contact time.
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
Alpha (p-nonylphenyl) Omega-Hydroxypoly (Oxyethylene) Iodine Complex (providing 1% titratable Iodine) .................................. 5%
Inert Ingredients
Water & Nonionic Surfactant ................................. 95%
CAUTION
Harmful or fatal if swallowed. Do not apply to the eyes, mucous membranes or large areas of abraded skin. Avoid inhalation of mist.KEEP TIGHTLY CLOSED WHEN NOT IN USE.
FOR EXTERNAL ANIMAL USE ONLY.
KEEP OUT REACH OF CHILDREN.
STORE AT 15o-30oC (59o-86oF) - PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
1% IODINE WOUND
iodine solutionProduct Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58305-027 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:58305-027-16 473 mL in 1 BOTTLE 2 NDC:58305-027-80 3785 mL in 1 JUG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 05/01/2014 Labeler - Centaur Inc (174239087) Establishment Name Address ID/FEI Business Operations Centaur Inc 174239087 api manufacture, manufacture