PEPSOM SALT PEPPERMINT- magnesium sulfate for solution

PEPSOM SALT PEPPERMINT by

Drug Labeling and Warnings

PEPSOM SALT PEPPERMINT by is a Otc medication manufactured, distributed, or labeled by The Pepsom Group, Inc., K+S KALI GmbH, Werk Werra, Standort Hattorf, PACA Foods, Inc., K+S KALI GmbH, Werk Werra, Standort Wintershall. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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 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