Label: PEPSOM SALT PEPPERMINT- magnesium sulfate for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51619-500-01, 51619-500-03, 51619-500-05 - Packager: The Pepsom Group, Inc.
- 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.
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Uses
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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
- 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
- Ask a doctor before use if you have
- Stop use and ask a doctor:
- When using this product
- Keep out of reach of children -
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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 obtainedLaxative:
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:
- Questions? Comments?
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Principal Display Panel
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 bruisesSaline Laxative
for relief of occasional constipationRelaxing Spa Bath
for relief of painTHE 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 ReconstructionPEPSOM 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 33137For information and more great tips -
Visit us at:
www.pepsom.com -
INGREDIENTS AND APPEARANCE
PEPSOM SALT PEPPERMINT
magnesium sulfate for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51619-500 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Magnesium Sulfate, Unspecified (UNII: DE08037SAB) (Magnesium Cation - UNII:T6V3LHY838) Magnesium Sulfate, Unspecified 1 kg in 1 kg Inactive Ingredients Ingredient Name Strength Peppermint (UNII: V95R5KMY2B) Silicon Dioxide (UNII: ETJ7Z6XBU4) Product Characteristics Color PINK Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51619-500-01 .454 kg in 1 BAG 2 NDC:51619-500-03 1.36 kg in 1 BAG 3 NDC:51619-500-05 2.27 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/21/2007 Labeler - The Pepsom Group, Inc. (012727382) Registrant - K+S KALI GmbH, Werk Werra, Standort Hattorf (507531213) Establishment Name Address ID/FEI Business Operations PACA Foods, Inc. 791804123 MANUFACTURE Establishment Name Address ID/FEI Business Operations K+S KALI GmbH, Werk Werra, Standort Wintershall 506759815 API MANUFACTURE