Label: EPSOM SALT- magnesium sulfate granule, for solution
- NDC Code(s): 72288-602-04, 72288-602-07, 72288-602-80
- Packager: Amazon.Com Services 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 July 7, 2022
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient
- Purpose
- Use
- 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 years - 1 to 2 level teaspoons (5 to 10 grams) daily
children under 6 years - consult a doctor
- Other information
- Invactive Ingredient
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soaking directions
For external use as a soaking aid for minor sprains and bruises.
DIRECTIONS: For a relaxing bath/soak, generously sprinkle Equate 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 phsician. Keep out of reach of children.
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SPL UNCLASSIFIED SECTION
Tamper Evident Packaging:
Caution: This package has been sealed for your protection. Do not use if package is open, torn or mutilated.
DISTRIBUTED BY:
Amazon.com, Services, Inc
Seattle, WA 98109
1-877-485-0385
2018 Amazon.com, Inc. or its afiliated.
All rights reserved. Solimo and all related logos are are trademarks of Amazon.com, Inc or its affiliates.
602.002/602AA
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INGREDIENTS AND APPEARANCE
EPSOM SALT
magnesium sulfate granule, for solutionProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:72288-602 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:72288-602-07 1810 g in 1 POUCH; Type 0: Not a Combination Product 05/01/2018 2 NDC:72288-602-80 3630 g in 1 POUCH; Type 0: Not a Combination Product 05/01/2018 3 NDC:72288-602-04 2720 g in 1 POUCH; Type 0: Not a Combination Product 05/01/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 05/01/2018 Labeler - Amazon.Com Services LLC (128990418) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(72288-602) Establishment Name Address ID/FEI Business Operations Vi-Jon 088520668 manufacture(72288-602)
