Label: PEPSOM FLYING P EPSOM SALT- magnesium sulfate for solution
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Contains inactivated NDC Code(s)
NDC Code(s): 51619-600-84 - 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 26, 2010
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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 bath 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
RESEALABLE POUCH CUT ALONG DOTTED LINE
Epsom Salt
MAGNESIUM SULFATE U.S.P.
Soaking Aid
- for minor sprains and bruises
Saline Laxative
- for relief of occasional constipation
NET WT 4 LB (1.81 kg)
RESEALABLE POUCH CUT ALONG DOTTED LINE
EPSOM SALT IS 100% NATURAL MINERAL (Magnesium Sulfate U.S.P.).
ENJOY THE MANY DELIGHTFUL USES AND BENEFITS OF THIS
PURE EPSOM SALT PRODUCT.EPSOM 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 A CUP INTO WASHCLOTH AND SCRUB OVER BODY TO EXFOLIATE SKIN - RINSE
SUMMER BUMMER? FOR CONCENTRATED RELIEF FROM STINGS OR PAIN, ADD 1/2 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
For external use as a soaking aid for minor sprains and bruises.
DIRECTIONS:
Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or toweling for 30 minutes up to 3 times a day, or use as a soak or in bath. Use warm water for best results.CAUTION:
If prompt relief is not obtained or if there is evidence of infection, discontinue use and consult your physician. Hot or warm soaks should not be used by individual with diabetes except on the advice of a physician.KEEP OUT OF REACH OF CHILDREN
100% Satisfaction-Guaranteed or your money back.
Distributed by:
The Pepsom Group, Inc. Miami, FL 33137
© The Pepsom Group, Inc.For information and more great tips
Visit us at:
www.pepsom.com -
INGREDIENTS AND APPEARANCE
PEPSOM FLYING P EPSOM SALT
magnesium sulfate for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51619-600 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 Product Characteristics Color WHITE Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51619-600-84 1.81 kg in 1 BAG Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 11/09/2009 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