Label: IODINE solution

  • NDC Code(s): 57561-030-16, 57561-030-80
  • Packager: Agri Laboratories, LTD
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated January 13, 2015

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  • INDICATIONS & USAGE

    Antiseptic/Disinfectant

    For animal use only.

    Keep out of reach of children.

    INDICATIONS

    Use as a topical antiseptic for superficial cuts, wounds, abrasions, insect bites and bruises on the skin of cattle, horses, dogs, sheep and swine.

    Topical Antiseptic

    For use as a counter-irritant in chronic inflammatory conditions.


  • DIRECTIONS

    If necessary, clip hair from area to be treated and cleanse with soap and water. Apply IODINE TINCTURE 2% not more than once daily. If repeated, dilute with 3 volumes of water. Do not bandage.

  • DOSAGE FORMS & STRENGTHS

    Active Ingredients

    Iodine .................................. 2%
    Sodium Iodide ...................... 2%
    Isopropyl Alcohol ................. 47%

    Inert Ingredients

    Water ................................. q.s.

  • WARNINGS AND PRECAUTIONS

    POISON

    First Aid: In case of ingestion, call Poison Control 1-800-222-1222

    CAUTION

    If redness, irritation or swelling persists or increases, discontinue use. Avoid contact with eyes and mucous membranes. Not for burns, deep wounds or body cavities.

    WARNING! FLAMMABLE!

    KEEP AWAY FROM HEAT AND OPEN FLAME.

    KEEP CONTAINER CLOSED WHEN NOT IN USE.


  • STORAGE AND HANDLING

    STORE AT 2o-30o (36o-86oF)

    PROTECT FROM LIGHT

  • PRINCIPAL DISPLAY PANEL

    AL Iodine Tincture 2

  • INGREDIENTS AND APPEARANCE
    IODINE  
    iodine solution
    Product Information
    Product TypeOTC ANIMAL DRUGItem Code (Source)NDC:57561-030
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4) IODINE0.02 mg  in 1 mL
    SODIUM IODIDE (UNII: F5WR8N145C) (IODIDE ION - UNII:09G4I6V86Q) IODIDE ION0.02 mg  in 1 mL
    ISOPROPYL ALCOHOL (UNII: ND2M416302) (ISOPROPYL ALCOHOL - UNII:ND2M416302) ISOPROPYL ALCOHOL0.47 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57561-030-16473 mL in 1 BOTTLE
    2NDC:57561-030-803785 mL in 1 JUG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other01/01/2010
    Labeler - Agri Laboratories, LTD (155594450)
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Safety

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