PEPSOM SPORTS WINTERGREEN- magnesium sulfate for solution

PEPSOM SPORTS WINTERGREEN by

Drug Labeling and Warnings

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

Drug Details [pdf]

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:

Carrot juice extract, silicon dioxide, wintergreen.

Questions? Comments?

1-877-FEEL-PEP

Principal Display Panel

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

WINTERGREEN

SOAKING AID FOR RELIEF OF
Pain  Sore Muscles Minor Sprains Bruises

NBATA ENDORSED
NATIONAL BASKETBALL ATHLETIC TRAINERS ASSOCIATIONTM

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

RESEALABLE POUCH CUT ALONG DOTTED LINE

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

THE ORIGINAL SPORT SOAKTM

WINTERGREEN

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.
• WINTERGREEN - 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 WINTERGREEN  
magnesium sulfate for solution

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 51619-300
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
Silicon Dioxide (UNII: ETJ7Z6XBU4)

Product Characteristics
Color	BLUE (Pale Blue)	Score
Shape		Size
Flavor		Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 51619-300-21	.454 kg in 1 BAG
2	NDC: 51619-300-23	1.36 kg in 1 BAG
3	NDC: 51619-300-25	2.27 kg in 1 BAG

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		09/05/2008

Labeler - The Pepsom Group, Inc. (012727382)

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

Establishment
Name	Address	ID/FEI	Business Operations
K+S KALI GmbH, Werk Werra, Standort Hattorf		507531213	API MANUFACTURE