EPSOM SALT- magnesium sulfate granule, for solution 
TOPCO Associates, LLC

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.

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Epsom Salt
029.003/602AA

Active ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

purpose

Saline laxative

Uses

Warnings

Ask a Doctor before use if you have

Ask a doctor or pharmacist before use if you are

taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if

 you have rectal bleeding or failure to have a bowel movement after use. These could be signs of a serious condition.

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

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

None

Other information

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 muscles

A 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 rejuvenated

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

topcare@topco@com

www.topcarebrand.com

image description

principal display panel

TopCare health

Epsom Salt

MAGNESIUM SULFATE U.S.P.

MgSO4 7H2O

NEW WT 8 LB (3.63 kg)

image description

EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76162-029
Route of AdministrationORAL, TOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE1 g  in 1 g
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76162-029-803630 g in 1 POUCH; Type 0: Not a Combination Product12/01/2021
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33412/01/2021
Labeler - TOPCO Associates, LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(76162-029)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(76162-029)

Revised: 1/2022
Document Id: c91cb020-17b4-407a-a5f2-3acb6e485cbf
Set id: b2ec06b3-647d-49ab-a392-6db63d96d1e3
Version: 9
Effective Time: 20220120
 
TOPCO Associates, LLC