Label: EPSOM SALT- magnesium sulfate crystal
- 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.
Updated August 11, 2017
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- SPL UNCLASSIFIED SECTION
- Active ingredient
- 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.
- 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
SPL UNCLASSIFIED SECTION
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 toweling for 30 minutes up to three times a day, or use as a soak or in a 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 individuals with diabetes except on the advice of a physician. Keep out of reach of children.
DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
- Principal Display Panel
INGREDIENTS AND APPEARANCE
magnesium sulfate crystal
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-602 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:37205-602-07 1814 g in 1 POUCH; Type 0: Not a Combination Product 03/26/2012 2 NDC:37205-602-43 454 g in 1 POUCH; Type 0: Not a Combination Product 03/26/2012 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part334 03/26/2012 Labeler - Cardinal Health (097537435) Registrant - Vi-Jon (790752542) Establishment Name Address ID/FEI Business Operations Vi-Jon 790752542 manufacture(37205-602)