Label: NATURAL EPSOM SALT- magnesium sulfate granule

  • NDC Code(s): 52000-420-16, 52000-420-22
  • Packager: Universal Distribution Center LLC
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated October 16, 2024

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • DRUG FACTS

  • Active Ingredient

    Magnesium Sulfate USP 100%

  • Purpose

    Internal Use.............................................Saline Laxative

    External Use...........................................Soaking Solution

  • INDICATIONS & USAGE

    INTERNAL USE
    • relieves occasional constipation (irregularity)
    • generally produces bowel movement in 1/2 to 6 hours

    EXTERNAL USE
    • Relieves pain from minor sprains and bruises

  • WARNINGS

    WARNINGS - Consult a doctor before use if you have:
    • kidney disease
    • a magnesium restricted diet
    • stomach pain, nausea or vomiting
    • noticed a sudden change in bowel habits that continues more than 2 weeks
    • already used a laxative for more than 1 week

    Consult a doctor or pharmacist before using if you are taking any other prescription drugs.

    Laxatives may affect how other drugs work.

    When using this product, DO NOT USE more than directed.

    Stop use and consult a doctor if:
    As Laxative:
    • you have rectal bleeding or failure to have a bowel movement after use
    • you need to use a laxative for more than 1 week

    As soaking solution:
    • you have redness, irritation, swelling, or infection occurs
    • do not use hot or warm soaks individuals with diabetes without consulting a doctor

    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 (1-800-222-1222) right away.

  • SPL UNCLASSIFIED SECTION

    UNSCENTED EPSOM SALT IS FOR INTERNAL AND EXTERNAL USE. SCENTED EPSOM SALTS ARE FOR EXTERNAL USE ONLY.

  • DIRECTIONS

     • do not exceed more than 2 doses per day

     Age Dose
    adults and children 12 years and older2 to 4 level teaspoons(10 to 20 grams) dissolved in a full glass (8oz) of water
    children 6 to under 12 years1 to 2 level teaspoons(5 to 10 grams) dissolved in a full glass (8oz) of water

    Not recommended for children under 6 years of age.

  • INACTIVE INGREDIENT

    None

  • SPL UNCLASSIFIED SECTION

    REGULAR UNSCENTED

    • A soaking aid for minor sprains & bruises

    • Use as a saline laxative

    • Great for gardening

    EXTERNAL USE

    SORE FEET RELIEF: Add 1 cup of Epsom Salt to 1 gallon of warm water and soak for minimum 5 minutes at a time.

    BATH SOAK: Add 2 cups of Epsom Salt under warm, running bath water. Soak for minimum 20 minutes to relieve tension and soothe sore tired muscles.

    FIRST AID COMPRESS: Dissolve 2 cups of Epsom Salt into two cups of hot water to make a compress, apply as a wet dressing with a towel to: soothe bruises & sprains, take the sting out of insect bites, draw out splinters, alleviate pain from sports and overexertion.

    KEEP OUT OF REACH OF CHILDREN. Where prompt relief is not obtained or where there is evidence of infection, discontinue use and consult a doctor. Hot or warm soaks should not be used by individuals with diabetes except on advice of a doctor. AVOID CONTACT WITH EYES.

    Store in a cool, dry place out of direct sunlight. Package sold by weight not volume. Some settling of content may occur during shipment. If caking occurs, tap pouch gently to free granules.

    Distributed By:
    Universal Distribution Center
    96 Distribution Boulevard
    Edison, NJ 08817
    www.universaldc.com

  • Packaging

    NATURAL Epsom Salt

  • INGREDIENTS AND APPEARANCE
    NATURAL EPSOM SALT 
    magnesium sulfate granule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-420
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM100 g  in 100 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52000-420-16454 g in 1 BOX; Type 0: Not a Combination Product11/01/2024
    2NDC:52000-420-22623 g in 1 BOX; Type 0: Not a Combination Product11/01/2024
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM00711/01/2024
    Labeler - Universal Distribution Center LLC (019180459)