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

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

  • 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

    Aspen Gentle Iodine 1

  • INGREDIENTS AND APPEARANCE
    GENTLE IODINE 1% 
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:46066-031
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.01 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R) 0.99 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:46066-031-91473 mL in 1 BOTTLE
    2NDC:46066-031-933785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2015
    Labeler - Aspen Veterinary Resources Ltd (627265361)
    Establishment
    NameAddressID/FEIBusiness Operations
    Centaur Inc174239087api manufacture, manufacture