TRIODINE 7- triple source iodine tincture solution

Triodine by

Drug Labeling and Warnings

Triodine by is a Animal medication manufactured, distributed, or labeled by Aspen Veterinary, FIRST PRIORITY INCORPORATED. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PURPOSE

Antiseptic/Disinfectant

KEEP OUT OF REACH OF CHILDREN

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). Keep container tightly closed when not in use.
PROTECT FROM LIGHT.

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.

INFORMATION FOR OWNERS/CAREGIVERS

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

Triodine-7 is a registered trademark of First Priority, Inc.

Manufactured for:
Aspen Veterinary Resources,® Ltd.
Liberty, MO 64068, USA
www.aspenveterinaryresources.com                      A279FP 7/16             A280FP 7/16          A281FP 7/16

NET CONTENTS:

16 fl oz (473 mL)

1 Quart (32 fl oz) (960 mL)

1 Gallon (128 fl oz) (3.785 L)

16 fl oz (473 mL)

32 fl oz (960 mL)

One Gallon (3.785 L)

INGREDIENTS AND APPEARANCE

TRIODINE  7
triple source iodine tincture solution

Product Information
Product Type	OTC ANIMAL DRUG	Item Code (Source)	NDC: 46066-326
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	2.1 mg  in 1 mL
POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4)	IODINE	3.0 mg  in 1 mL
POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q)	IODIDE ION	2.0 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 46066-326-16	12 in 1 CASE
1		473 mL in 1 BOTTLE, SPRAY
2	NDC: 46066-326-32	16 in 1 CASE
2		960 mL in 1 BOTTLE
3	NDC: 46066-326-01	4 in 1 CASE
3		3785 mL in 1 JUG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		07/15/2016

Labeler - Aspen Veterinary (627265361)

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