Label: PEPSOM SPORTS SPEARMINT- magnesium sulfate for solution

  • Category: HUMAN OTC DRUG LABEL

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 May 27, 2010

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  • Active Ingredient

    Magnesium Sulfate U.S.P. 100% (Epsom salt)

  • Purpose

    Soaking Solution

  • Uses

    For relieving muscle strains and soreness from working out

  • Warnings

    For external use only

  • Ask a doctor before use if you have

    • redness or swelling present
    • evidence of an infection
    • diabetes
  • When using this product

    • avoid contact with eyes or mucus membranes
  • Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    Bath- Soaking Aid

    Dissolve 2 cups into a tub of hot water and soak for 15-30 minutes.

    Foot or Wrist Soak

    Dissolve 2 cups into a foot-soaking tub half-full of water, soaking the injured area for 20-30 minutes. Repeat 2-3 times per day until relief is obtained.

  • Inactive ingredients:

    Silicon dioxide, sodium copper chlorophyllin, spearmint.

  • Questions? Comments?

    1-877-FEEL-PEP

  • Principal Display Panel

    label

    SOAKING AID FOR RELIEF OF PAIN AND SORE MUSCLES

    BLENDED WITH 100% NATURAL MINERAL+ MINT

    NEW SOAKING AID

    RESEALABLE POUCH CUT ALONG DOTTED LINE

    PEPSOM SPORTS®

    THE ORIGINAL SPORT SOAKTM

    MAGNESIUM SULFATE U.S.P. + MINT

    FIRE ICE FORMULA

    SPEARMINT

    SOAKING AID FOR RELIEF OF
    Pain • Sore Muscles • Minor Sprains • Bruises

    NBATA ENDORSED
    NATIONAL BASKETBALL ATHLETIC TRAINERS ASSOCIATIONTM

    NET WT. 48 OZ. (3 lbs.) 1.36 kg

    RESEALABLE POUCH CUT ALONG DOTTED LINE

    PEPSOM SPORTS®
    MAGNESIUM SULFATE U.S.P. + MINT

    THE ORIGINAL SPORT SOAKTM

    SPEARMINT

    ENDORSED BY
    NATIONAL BASKETBALL ATHLETIC TRAINERS ASSOCIATIONTM

    The NBATA Mark is a trademark of the NBATA and is being used by
    The Pepsom Group, Inc. under license from NBATA

    A NEW PRODUCT created for athletes and "Weekend Warriors" of all ages!

    PEPSOM SPORTS® is a blend of 100% NATURAL INGREDIENTS that help to reduce Sport-related and other minor aches and pains, bruises and strains.  EVEN IF YOU HAVE NO SORENESS OR PAIN, YOU WILL LOVE PEPSOM SPORTS®, THE ORIGINAL SPORT SOAK™.

    ENDORSED BY the NBATA™
    National Basketball Athletic Trainers Association™

    • PROFESSIONAL SPORTS ATHLETIC TRAINERS have long known that SOAKING can often bring comfort and relief from aches and pains originating from sports overexertion. Our ORIGINAL SPORT SOAK™ is endorsed by the NBATA™ the National Basketball Athletic Trainers Association™ (Please visit their website to know more about this elite association of top professional athletic trainers, at www.nbata.com).

    FIRE ICE FORMULA

    Combining the "FIRE" of HYDROTHERAPY (treatment for injury with water) to SOAK AWAY PAIN together with the cooling "ICE" sensation of MINT to REFRESH EVERY MUSCLE.

    PEPSOM SPORTS® "FIRE★ICE" Formula combines an age-old remedy with some of the ingredients used for decades by some of the TOP ATHLETIC TRAINERS of the sporting world....special formulations that they've been using to ease sore muscles, pain, soreness, bruises and muscle pulls.

    • BLENDED WITH 100% NATURAL MINERAL + other NATURAL INGREDIENTS
    • MAGNESIUM SULFATE U.S.P. (also known as EPSOM SALT) has been used over generations for pain relief and other minor sports injuries including spasms, sprains, bruises and muscle pulls.
    • SPEARMINT - Cooling and Refreshing

    WHEN TO USE

    BEFORE WORKOUT/GAME: Soaking in a very warm bath with PEPSOM SPORTS® can help relax your muscles and get you ready for pre-game warm ups or sports activity. Some of the possible benefits:

    • Relaxes joints and muscles, which may add flexibility to help reduce risk of injury.
    • Soothes aches and soreness from previous workouts
    • Calming effect - eases tension, allowing you to focus on your goal

    AFTER A HARD WORKOUT or GAME: Using PEPSOM SPORTS® for a hot soak or in the shower will begin to soothe away your hard-earned aches and pains. Some of the possible benefits:

    • Soothes painful bruises and strains.
    • Soaks away stress and helps to remove toxins
    • Reduces or eliminates tomorrow's stiffness

    100% Satisfaction guaranteed or your money back.

    Distributed by:
    The Pepsom Group, Inc. Miami, FL 33137
    © The Pepsom Group, Inc. Miami, FL 33137

    THE NBATA Mark is a trademark of the NBATA and is being used by The Pepcom Group, Inc. under license from NBATA

    Learn more about them at:
    www.nbata.com

    Visit us at:
    www.pepsomsports.com or
    www.pepsom.com

  • INGREDIENTS AND APPEARANCE
    PEPSOM SPORTS SPEARMINT  
    magnesium sulfate for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51619-400
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Magnesium Sulfate, Unspecified (UNII: DE08037SAB) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Sulfate, Unspecified1 kg  in 1 kg
    Inactive Ingredients
    Ingredient NameStrength
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Spearmint (UNII: J7I2T6IV1N)  
    Product Characteristics
    ColorGREEN (Pale Green) Score    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51619-400-41.454 kg in 1 BAG
    2NDC:51619-400-431.36 kg in 1 BAG
    3NDC:51619-400-452.27 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other09/05/2008
    Labeler - The Pepsom Group, Inc. (012727382)
    Establishment
    NameAddressID/FEIBusiness Operations
    PACA Foods, Inc.791804123MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    K+S KALI GmbH, Werk Werra, Standort Wintershall506759815API MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    K+S KALI GmbH, Werk Werra, Standort Hattorf507531213API MANUFACTURE