Label: TRIODINE 7- triple source iodine tincture solution

  • NDC Code(s): 46066-326-01, 46066-326-16, 46066-326-32
  • Packager: Aspen Veterinary
  • 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 January 27, 2017

If you are a consumer or patient please visit this version.

  • 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.

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  • 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)

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    32 fl oz (960 mL)

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    One Gallon (3.785 L)

    image of LBASTP138_r0716

  • INGREDIENTS AND APPEARANCE
    TRIODINE  7
    triple source iodine tincture solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-326
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE2.1 mg  in 1 mL
    POVIDONE-IODINE (UNII: 85H0HZU99M) (IODINE - UNII:9679TC07X4) IODINE3.0 mg  in 1 mL
    POTASSIUM IODIDE (UNII: 1C4QK22F9J) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION2.0 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-326-1612 in 1 CASE
    1473 mL in 1 BOTTLE, SPRAY
    2NDC:46066-326-3216 in 1 CASE
    2960 mL in 1 BOTTLE
    3NDC:46066-326-014 in 1 CASE
    33785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other07/15/2016
    Labeler - Aspen Veterinary (627265361)
    Establishment
    NameAddressID/FEIBusiness Operations
    FIRST PRIORITY INCORPORATED179925722manufacture, label