Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 55316-602-06, 55316-602-07
- Packager: DZA Brands, LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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 December 8, 2022
If you are a consumer or patient please visit this version.
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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 - 1 to 2 level teaspoons (5 to 10 grams) daily
children under 6 years of age - consult a doctor
- Other information
- Inactive Ingredients
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SPL UNCLASSIFIED SECTION
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
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SPL UNCLASSIFIED SECTION
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.
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55316-602 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:55316-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 02/27/2008 2 NDC:55316-602-06 454 g in 1 POUCH; Type 0: Not a Combination Product 02/27/2008 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 02/27/2008 Labeler - DZA Brands, LLC (090322194) Registrant - Vi-Jon, LLC (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 790752542 manufacture(55316-602) Establishment Name Address ID/FEI Business Operations Vi-Jon, LLC 088520668 manufacture(55316-602)
