Triodine: Product Information

TRIODINE- iodine, povidone-iodine and potassium iodide solution
FIRST PRIORITY INCORPORATED

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.

Triple Source Iodine Tincture Antiseptic / Disinfectant

For Animal Use Only • Keep Out of Reach of Children

INDICATIONS:

For use on cattle, sheep, horses, dogs, and swine. For topical application on the skin to disinfect superficial wounds, cuts, abrasions, insect bites and minor bruises.

DIRECTIONS FOR USE:

If necessary, clip hair from area to be treated and cleanse with soap and water. Apply Triodine-7^® with a swab.

CAUTION:

Not for use in body cavities or deep wounds. Do not use on burns. Do not apply under bandage. Irritation may occur if used on tender skin areas. Avoid contact with eyes and mucous membranes. In case of deep or puncture wounds or serious burns, consult a veterinarian. If redness, irritation, or swelling persists or increases, discontinue use and consult a veterinarian.

STORAGE:

Store at controlled room temperature between 15°-30°C (59°-86°F). PROTECT FROM LIGHT.

Triodine-7 and Priority Care are registered trademarks of First Priority, Inc.

ACTIVE INGREDIENTS:

7% active ingredients provided by Povidone Iodine, Iodine and Potassium Iodide. Provides 2.4% Titratable Iodine*.

INACTIVE INGREDIENTS:

Water, Isopropyl Alcohol and Propylene Glycol.

WARNING:

Ingestion may cause gastrointestinal irritation, nausea and vomiting.

CALL A PHYSICIAN OR POISON CONTROL CENTER. WARNING! FLAMMABLE! KEEP AWAY FROM HEAT AND OPEN FLAME. KEEP CONTAINER CLOSED WHEN NOT IN USE.

Restricted Drug — Use Only as Directed.

Not For Human Use.

Net Contents:

16 fl oz (473 mL) Reorder No. TP135PC

32 fl oz (960 mL) Reorder No. TP137PC

One Gallon (3.785 L) Reorder No. TP138PC

*Complies with DEA Iodine Regulation 21 C.F.R. §1310.12. No DEA registration required.

Made in U.S.A.

Manufactured By: FIRST PRIORITY, INC., Elgin, IL 60123-1146

www.prioritycare.com

NOT RETURNABLE IF OUTDATED

16 fl oz (473 mL)

32 fl oz (960 mL)

One Gallon (3.785 L)

TRIODINE triple source iodine tincture solution

Product Information Product Type OTC ANIMAL DRUG Item Code (Source) NDC:58829-326 Route of Administration TOPICAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength IODINE (IODINE) IODINE 2.1 mg in 1 mL POVIDONE-IODINE (IODINE) IODINE 3.0 mg in 1 mL POTASSIUM IODIDE (IODIDE ION) IODIDE ION 2.0 mg in 1 mL

Packaging # Item Code Package Description Multilevel Packaging 1 NDC:58829-326-16 12 BOTTLE, SPRAY in 1 CASE contains a BOTTLE, SPRAY 1 473 mL in 1 BOTTLE, SPRAY This package is contained within the CASE (58829-326-16) 2 NDC:58829-326-32 16 BOTTLE in 1 CASE contains a BOTTLE 2 960 mL in 1 BOTTLE This package is contained within the CASE (58829-326-32) 3 NDC:58829-326-01 4 JUG in 1 CASE contains a JUG 3 3785 mL in 1 JUG This package is contained within the CASE (58829-326-01)

Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 10/13/2014

Labeler — FIRST PRIORITY INCORPORATED (179925722)

Establishment
Name	Address	ID/FEI	Operations
FIRST PRIORITY INCORPORATED		179925722	manufacture, label

Revised: 06/2022 FIRST PRIORITY INCORPORATED