EPSOM SALT- magnesium sulfate granule, for solution 
DZA Brands, 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
602.002/602AA

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 durgs.  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 coud 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 - 1 to 2 level teaspoons (5 to 10 grams) daily

children under 6 years of age - consult a doctor

Other information

Inactive Ingredients

None

Tamper Evident Packaging:
Caution this packasge has been sealed for your protection. Do not use if package is open, torn or mutilated.

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 three tmes a day, or use as a soak or in bath. Use warm water for best results

Distributed by: DZA Brands, LLC

Salisbury, NC 28147

Scarborough, ME 04074

For product questions or concerns contact us at 1-866-322-2439

Please include UPC code and code from the package

Healthy Accents

Magnesium sulfate USP

Epsom Salt

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 towelling for 30 minutes up to three times a day or use in a soak or in bath. Use warm water for best results

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 indifiduals with diabetes except on the advice of a physician. Keep out of reach of children.

PRINCIPAL DISPLAY PANEL

healthy accents

magnesium sulfate USP

epsom salt

saline laxative for relief of occasional constipation

soaking aid for minor sprains and bruises

NET WT 1 LB (454 g) 16 OZ

image description

EPSOM SALT 
magnesium sulfate granule, for solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55316-602
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:55316-602-071814 g in 1 POUCH; Type 0: Not a Combination Product02/27/2008
2NDC:55316-602-06454 g in 1 POUCH; Type 0: Not a Combination Product02/27/2008
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/27/2008
Labeler - DZA Brands, LLC (090322194)
Registrant - Vi-Jon, LLC (790752542)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC790752542manufacture(55316-602)
Establishment
NameAddressID/FEIBusiness Operations
Vi-Jon, LLC088520668manufacture(55316-602)

Revised: 12/2022
Document Id: 4aed384c-8a0b-4886-a976-ff80d5bd6744
Set id: fcf23dab-ee8a-4c0c-8d47-513da2324200
Version: 11
Effective Time: 20221208
 
DZA Brands, LLC