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
602.02/602AA

Active ingredient

Magnesium sulfate USP ( Heptahydrate) 100%

purpose

Saline laxative

Uses

Uses for Oral Laxative

For Soaking

For external use as a soaking aid for minor sprains and bruises.

Warnings

Warnings for Soaking

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.

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

Directions for Soaking

Directions: Dissolve 2 cupfuls of this product per gallon of water. Apply with bandages or towelling for 30 minutes up to three times a day, or use as a soak or in bath. Use warm water for best results.

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

DISTRIBUTED BY TOPCO ASSOCIATES, LLC

ELK GROVE VILLAGE, IL 60007

1-888-423-0139

topcare@topco@com

602.002/602AA

principal display panel

Cut along dotted line and press zipper to reseal.

TopCare health

Epsom

Salt

MAGNESIUM SULFATE U.S.P.

NEW WT 64OZ (4 LB) 1.81 kg

image description

EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-602
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:36800-602-43454 g in 1 POUCH; Type 0: Not a Combination Product07/15/1999
2NDC:36800-602-071814 g in 1 POUCH; Type 0: Not a Combination Product07/15/1999
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/15/1999
Labeler - TOPCO Associates, LLC (006935977)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(36800-602)

Revised: 12/2022
Document Id: cf0717a9-c00d-46ca-b3f1-3f376e046793
Set id: 72f69aa0-381a-4e5c-975d-3a73fdc1b377
Version: 13
Effective Time: 20221216
 
TOPCO Associates, LLC