Label: SOFTKOTE - iodine liquid 

  • NDC Code(s): 50138-544-01, 50138-544-02, 50138-544-03, 50138-544-04, view more
    50138-544-05, 50138-544-06, 50138-544-07, 50138-544-08
  • Packager: EXL Laboratories, LLC
  • Category: OTC ANIMAL DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 11/13

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

  • Directions Teat irritation or chapping Active ingredients

    1 % IODINE POST-MILKING TEAT DIP

    USAGE DIRECTIONS:

    POST-DIPPING: Dip teats with undiluted product after milking. Allow to air dry.  With freshening cows, begin dipping teats twice daily for about 10 days before calving. For dry cows, dip teats once a day for 3-4 days following the last milking. DURING COLD WEATHER, do not turn out cows until teats are dry.
    UDDER WASH: To avoid contamination of milk, wash teats with this product diluted at 1 oz. (30 ml) per 2-4 gallons (8 - 16L) of lukewarm water. Then dry each cow’s udder and teats with clean towels before milking.
    DO NOT USE THIS PRODUCT FOR CLEANING AND/OR SANITIZING EQUIPMENT.
    IMPORTANT: TEAT IRRITATION OR CHAPPING:
      Teat dips have the potential to cause irritation or chapping. If you observe abnormal irritation or chapping,  call 1-800-225-3832 or contact your dealer.
    ACTIVE INGREDIENTS: Nonylphenoxypolyethoxy (12 moles EO) ethanol-iodine complex providing 1.0% titratable iodine (10.000 mg/L)
    Contains 12% skin conditioners.

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  • Caution First Aid Storage and Spillage

    CAUTION
    KEEP OUT OF THE REACH OF CHILDREN
    HARMFUL IF SWALLOWED – HARMFUL IF INHALED – CAUSES EYE IRRITATION
    SEE BELOW INFORMATION FOR ADDITIONAL PRECAUTIONS OR CONSULT MSDS SHEET
    TOLL FREE EMERGENCY NUMBER: 1-800-424-9300
    PRECAUTIONS:
    Protect eyes from contact with this product. Keep container tightly closed when not in use. Use with adequate ventilation. Wash thoroughly after handling product.

    FIRST AID:
    EXTERNAL:
    In case of contact, immediately flush contaminated skin with plenty of water. If irritation occurs and persists, call a physician.
    INTERNAL: If conscious, dilute by giving several glasses of water or milk. Do not induce vomiting. If vomiting does occur, repeat giving several glasses of water or milk. Give prompt medical attention. NEVER GIVE ANYTHING BY MOUYH TO AN UNCONSCIOUS PERSON
    EYES: Immediately flush with plenty of clean, running water for at least 15 minutes, holding eyelids apart to ensure flushing of the entire eye surface. If irritation persists, call a physician.
    STORAGE AND   DISPOSAL: Store this product in a cool, dry area away from direct sunlight and heat to avoid deterioration. Store in a locked cabinet or room to keep it out of the reach of children. Dispose of according to Federal, State, and local laws.
    SPILLAGE: In case of a small spill (less than one gallon) flood area with a large quantity of water. For larger spills, contain and remove with inert absorbent and dispose of according to Federal, State, and local laws.
    KEEP FROM FREEZING.

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  • Product Label

    A and L
    Laboratories

    SOFTKOTE™

    Manufactured  by
    EXL Laboratories, LLC. 
    1011  Glenwood Avenue, Minneapolis, MN 55405  Toll free 1-800-225-3832

    Part # 544

    Net Contents:  55 GALLONS (208.2 L)
    Lot #: 00011052A  Expires: 11/2014

    EXL Labs SOFTKOTE Label

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  • INGREDIENTS AND APPEARANCE
    SOFTKOTE 
    iodine liquid
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:50138-544
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (IODINE) IODINE 10000 mg  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50138-544-01 9.5 L in 1 JUG
    2 NDC:50138-544-02 19 L in 1 JUG
    3 NDC:50138-544-03 56.8 L in 1 DRUM
    4 NDC:50138-544-04 114 L in 1 DRUM
    5 NDC:50138-544-05 208.3 L in 1 DRUM
    6 NDC:50138-544-06 946 L in 1 DRUM
    7 NDC:50138-544-07 1003 L in 1 DRUM
    8 NDC:50138-544-08 1040 L in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 03/01/1997
    Labeler - EXL Laboratories, LLC (927483458)
    Registrant - EXL Laboratories, LLC (927483458)
    Establishment
    Name Address ID/FEI Business Operations
    EXL Laboratories, LLC 927483458 api manufacture, manufacture
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