Label: PEPSOM SALT PEPPERMINT- magnesium sulfate for solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by 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 May 27, 2010

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

  • Active Ingredient

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

  • Purpose

    External...................Soaking Solution
    Internal.......................Saline Laxative

  • Uses

    External-
    Soaking Solution.............Relieves muscle strains and soreness
    Internal-
    Saline Laxative........................Relieves occasional constipation

  • Warnings

    Laxative

    • For occasional use only. Serious side effects from prolonged use or overdosage may occur. Do not take this product except under the advice and supervision of physician if you 
      • have kidney disease
      • are taking medications
      Do not give to children under 6 years of age except under the advice and supervision of a physician.
  • Ask a doctor before use if you have

    Soaking Solution

    • redness or swelling present
    • evidence of an infection
    • diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of physician

    Laxative

    • kidney disease
    • stomach pain
    • nausea
    • a sudden change in bowel habits that lasts over 2 weeks
  • Stop use and ask a doctor:

    Laxative

    • if you have no bowel movement within 6 hours or rectal bleeding. These could be signs of a serious condition
    • you need a laxative for more than one week
  • When using this product

    • avoid contact with eyes or mucus membranes

  •  

    If pregnant or breast-feeding ask a health professional before use

  • Keep out of reach of children -

    In case of overdose get medical help or contact a Poison Control Center right away

  • Directions

    Soaking Solution:

    Bath - 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

    Laxative:

    Children 6-12 years.........................Dissolve 1-2 level teaspoons
    (5mg-10mg) into a full cup of water (8oz)
    Adults and Children over 12.........Dissolve 2-4 level teaspoons
    (10mg-20mg) into a full cup of water (8oz)

  • Inactive ingredients:

    Carmine, peppermint, silicon dioxide.

  • Questions? Comments?

    1-877-FEEL-PEP

  • Principal Display Panel

    label

    JUST LIKE REGULAR EPSOM SALT, BUT MORE REFRESHING

    BLENDED WITH 100% NATURAL MINERAL+ MINT

    NEW AND REFRESHING

    RESEALABLE POUCH CUT ALONG DOTTED LINE

    PEPSOM SALT®

    MAGNESIUM SULFATE U.S.P. + MINT

    PEPPERMINT

    Soaking Aid
    for minor sprains and bruises

    Saline Laxative
    for relief of occasional constipation

    Relaxing Spa Bath
    for relief of pain

    THE EPSOM WITH PEP™

    NET WT. 16 OZ (1 lb.) 454 g

    RESEALABLE POUCH CUT ALONG DOTTED LINE

    THE EPSOM WITH PEP™

    SOAKING AID FOR PAIN RELIEF • SALINE LAXATIVE

    "PEPSOM Salt® clearly takes a step forward in making an already proven and widely-used product even more beneficial."

    Dr. Gary Goykhman
    Doctor of Podiatric Medicine (D.P.M.)
    Foot and Ankle Specialist
    Miami Institute for Joint Reconstruction

    PEPSOM SALT® IS A SPARKLING BLEND OF 100% NATURAL MINERAL (EPSOM SALT) AND OTHER EXCITING INGREDIENTS. ENJOY THE NEW COOLING SENSATION AND ENHANCED BENEFITS OF 100% NATURAL PEPPERMINT.

    PEPSOM SALT® - "THE EPSOM WITH PEP ™"!

    EVEN IF YOU HAVE NO SORENESS OR PAIN, YOU WILL LOVE THE SOOTHING EFFECT OF PEPSOM SALT ™!

    FOR EVERY SEASON

    WINTER BLUES? ADD 2 CUPS TO A WARM/HOT BATH. SOAK 15-30 MIN FOR RELIEF OF ACHES AND PAINS

    SPRING BREAK? ADD HANDFULS INTO WASHCLOTH AND SCRUB OVER BODY TO EXFOLIATE SKIN - RINSE

    SUMMER BUMMER? FOR CONCENTRATED RELIEF FROM STINGS OR PAIN, ADD ½ CUP TO 1 QT. OF WATER - MAKE A DRESSING AND WRAP INJURED AREA 2-3 X A DAY

    FALL SHORT? FOR FOOT PAIN, ADD 1-2 CUPS INTO FOOTBATH OF VERY WARM WATER - SOAK 20-30 MIN

    100% Satisfaction-Guaranteed or your money back.

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

    For information and more great tips -
    Visit us at:
    www.pepsom.com

  • INGREDIENTS AND APPEARANCE
    PEPSOM SALT PEPPERMINT  
    magnesium sulfate for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51619-500
    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
    Peppermint (UNII: V95R5KMY2B)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Product Characteristics
    ColorPINKScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51619-500-01.454 kg in 1 BAG
    2NDC:51619-500-031.36 kg in 1 BAG
    3NDC:51619-500-052.27 kg in 1 BAG
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33405/21/2007
    Labeler - The Pepsom Group, Inc. (012727382)
    Registrant - K+S KALI GmbH, Werk Werra, Standort Hattorf (507531213)
    Establishment
    NameAddressID/FEIBusiness Operations
    PACA Foods, Inc.791804123MANUFACTURE
    Establishment
    NameAddressID/FEIBusiness Operations
    K+S KALI GmbH, Werk Werra, Standort Wintershall506759815API MANUFACTURE