EPSOM SALT- magnesium sulfate granule, for solution 
FOODHOLD U.S.A., 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

TEP

Tamper Evident Packaging:

Caution: this package has been sealed for your protection.

Do not use if package is open, torn or mutilated

Claims

Epsom Salt

Magnesium Sulfate U.S.P.

MgSO4 - 7H2O

Active ingredient

Magnesium sulfate USP (heptahydrate) 100%

Purpose

Saline Laxative

External use soaking aid

Uses

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

Warnings

CAUTION: If prompt relief is not obtained or there is evidence of infection, discontinue use and consult your physician.

Hot or warms soaks should not be used by individuals with diabetes except on the advice of a physican

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:

Dissolve 2 cups of CareOne Epsom Salt per fallon of water.  Apply with bandages or toweling for 30 minutes up to three times a day.  For less intensive soak, use 1 or 2 cups in a bath.  Use warm water for best results

Other information

Adverse Reactions

DISTRIBUTED BY:

FOODHOLD U.S.A., LLC

LANDOVER, MD 20785

Quality Guaranteed or your money back.

principal display panel

CAREONE

EPSOM

SALKT

MAGNESIUM SULFATE U.S.P.

For relief of occasional constipation

For minor sprains and bruises

NET WT 16 OZ

(1 LB) 454 g

image description

EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41520-055
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:41520-055-43454 g in 1 POUCH; Type 0: Not a Combination Product
2NDC:41520-055-071814 g in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/06/2015
Labeler - FOODHOLD U.S.A., LLC (809183973)
Registrant - Vi-Jon (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon790752542manufacture(41520-055)

Revised: 5/2015
Document Id: 66934973-59db-458d-8f88-43e4228652d5
Set id: f2a8c16e-ea6c-4b71-8871-5fcf910df053
Version: 1
Effective Time: 20150515
 
FOODHOLD U.S.A., LLC