Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 76162-029-80
- Packager: TOPCO Associates, LLC
- Category: HUMAN OTC DRUG LABEL
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 January 20, 2022
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- Official Label (Printer Friendly)
- Active ingredient
- purpose
- Uses
- WARNINGS
- Ask a Doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Stop use and ask a doctor if
- If pregnant or breast-feeding
- Keep out of reach of children.
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directions
- do not exceed recommended daily dosage
- drink a full glass (8 ounces) of liquid with each dose
- may be taken as a single daily dose or in divided doses
- dissolve the dose in 8 ounces of water. Lemon juice may be added to improve the taste
adults and children 12 years and over - 2 to 6 level teaspoons (10 to 30 grams) daily
children 6 to under 12 years - 1 to 2 level teaspoons (5 to 10 grams) daily
children under 6 years - consult a doctor
- inactive ingredients
- Other information
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SPL UNCLASSIFIED SECTION
Tamper Evident Packaging:
Caution: This package has been sealed for your protection. Do not use if package is open, torn or multiated. Cut along dotted line and press zipper to reseal.
SOAKING SOLUTION
For external use as a soaking aid for minor sprains and bruises. Discover the relaxing spa like qualities of this product in your bath.DIRECTIONS: For a relaxing bath/soak, generously sprinkle TopCare Epsom Salt into warm, running bath water.
CAUTION: IF PROMPT RELIEF IS NOT OBTAINED OR THERE IS EVIDENCE OF INFECTION, DISCONTINUE USE AND CONSULT YOUR PHYSICIAN. HOT OR WARM SOAKS SHOULD NOT BE USED BY INDIVIDUALS WITH DIABETES EXCEPT ON THE ADVICE OF A PHYSICIAN. KEEP OUT OF REACH OF CHILDREN.BEAT WINTER BLUES
Simply dissolve two cups of epsom salt in a warm bath:
• for a calm and refreshing soak
• to warm and relax your musclesA MINERAL SPRING SPA
Springtime is your fresh start to working out, often leading to overexertion. Just dissolve two cups of epsom salt in warm bath water, settle in and experience the relief and relaxation.SOAK IN SUMMER SALTS
Summertime is filled with fun outdoor activities like hiking, playing sports, gardening in your backyard and more. Dissolve two cups of epsom salt in warm bath water to soothe away your muscle aches and pains that summer fun activities can bring.RELAX INTO AUTUMN
By dissolving two cups of epsom salt in a warm bath, you'll be able to:
• revitalize tired and aching muscles
• feel refreshed and rejuvenatedDISTRIBUTED BY TOPCO ASSOCIATES, LLC
ELK GROVE VILLAGE, IL 60007
1-888-423-0139
topcare@topco@com
www.topcarebrand.com
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76162-029 Route of Administration ORAL, TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 1 g in 1 g Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:76162-029-80 3630 g in 1 POUCH; Type 0: Not a Combination Product 12/01/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 12/01/2021 Labeler - TOPCO Associates, LLC (006935977) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(76162-029) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(76162-029)
