Label: ASPEN IODINE CONCENTRATE 15X - iodine liquid 

  • NDC Code(s): 50138-033-01, 50138-033-02, 50138-033-03, 50138-033-04, view more
    50138-033-05, 50138-033-06, 50138-033-07, 50138-033-08
  • 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.

  • Usage Directions Active Ingredient

    USAGE DIRECTIONS
    Concentrated teat dip. Do not use as-is. Must be diluted before use.

    MIXING DIRECTIONS
    - 1% Iodine Teat Dip: Mix 1 part product with 3 parts potable water
    - 0.5% Iodine Teat Dip: Mix 1 part product with 7 parts potable water
    - 0.25% Iodine Teat Dip: Mix 1 part product with 15 parts potable water

    PRE-DIPPING/SPRAYING: Teats should be clean and dry before dipping. Dip/spray with diluted product and allow 30-60 seconds contact time. Wipe the teats dry.

    POST-DIPPING/SPRAYING:
    Dip/spray teats with diluted 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 spray 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:
    Cow's teats should be washed just prior to milking, using ready-to-use product as one of the following dilutions: 0.25% iodine = 2oz/gal (60mL/4L); 0.5% iodine = 1oz/gal (30mL/4L); 1% iodine = 1oz/2gal (30mL/8L)

    DO NOT USE THIS PRODUCT FOR CLEANING AND/OR SANITIZING EQUIPMENT
    ACTIVE INGREDIENTS: Nonylphenolyethoxy (12 moles EO) ethanol-iodine complex providing 4% titratable iodine (40,000 ppm)

    Contains skin conditioners.

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  • Caution First Aid Storage and Disposal

    CAUTION
    KEEP OUT OF REACH OF CHILDREN
    HARMFUL IF SWALLOWED – HARMFUL IF INHALED – CAUSES EYE IRRITATION
    SEE BELOW 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 MOUTH 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 small spill (less than one gallon), flood area with 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

    Aspen ®
    Dairy Solutions™
    QUALITY MILK CONTROL™

    IODINE CONCENTRATE 15X

    IODINE CONCENTRATE 15X is a highly concentrated product. When properly diluted with potable water, it will create a safe, effective, and gentle iodine teat dip.

    EXL Laboratories,  LLC. 
    1001 Glenwood Ave. 
    Minneapolis, MN 55405

    Net Contents:  5  Gals. (18.9 L)          15 Gals. (56.8 L)
                         30 Gals. (113.6 L)         55 Gals. (208 L)
                       265 Gals. (1003 L)                           

    Control: 81405033A

    Lot Number/Expires:

    EXL Lab IODINE CON15X Label

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  • INGREDIENTS AND APPEARANCE
    ASPEN IODINE CONCENTRATE 15X 
    iodine liquid
    Product Information
    Product Type OTC ANIMAL DRUG LABEL Item Code (Source) NDC:50138-033
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    IODINE (IODINE) IODINE 40000 mg  in 1 L
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50138-033-01 9.5 L in 1 JUG
    2 NDC:50138-033-02 18.9 L in 1 JUG
    3 NDC:50138-033-03 56.8 L in 1 DRUM
    4 NDC:50138-033-04 113.6 L in 1 DRUM
    5 NDC:50138-033-05 208 L in 1 DRUM
    6 NDC:50138-033-06 946 L in 1 DRUM
    7 NDC:50138-033-07 1003 L in 1 DRUM
    8 NDC:50138-033-08 1040 L in 1 DRUM
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    unapproved drug other 09/01/2012
    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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