Label: HEALTH SMART NATURAL EPSOM SALT- magnesium sulfate granule, for solution

  • 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 October 28, 2013

If you are a consumer or patient please visit this version.

  • Active Ingredient

    Magnesium Sulfate USP (Epsom Salt)

  • Purpose

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

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

  • INDICATIONS & USAGE

    Uses (Internal)

    • Relieves occasional constipation (irregularity)
    • Generally produces bowel movements in 1/2 to 6 hours

    Uses (External)

    • Relieves pain from major sprains and bruises
  • Warnings - Ask a doctor before use if you have:

    • Kidney disease
    • a magnesium restricted diet
    • abdominal pain, nausea or vomiting
    • noticed a sudden change in bowel habbits that persists over a period of 2 weeks
    • already used a laxative for a period longer than 1 week

    Ask a doctor or pharmacist before use if you are presently taking any other drug. Take this product 2 or more hours before or after other drugs. Laxatives may affect how other drugs work.

  • When using this product, do not use more than directed.

  • Stop and consult a doctor if:

    As Laxative:

    • you have rectal bleeding or fail to have a bowel movement after use. This may indicate a serious condition
    • you need to use a laxative for more than 1 week

    As soaking solution:

    • you have redness, irritation, swelling or infection occurs
    • hot or warm soaks should not be used by individuals with diabeties except with the advice of a physician 
  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health profesional before use.

  • KEEP OUT OF REACH OF CHILDREN

    Keep this and all drugs out of the reach of children. In the case of an accidental overdose, seek professional assistance or contact Poison Control Center immedietly.

    EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE,
    SCENTED EPSOM SALTS CAN BE APPLIED FOR EXTERNAL USE ONLY

  • INDICATIONS & USAGE

    Directions for Internal Use as a Laxative

    • do not exceed more than 2 doses per day
    • may be taken as a single daily dose or in divided doses
    • dissolve each dose in a full (8 ounces) of liquid
    AgeDose
    adults and children 12 years and older2 to 4 level teaspoons (10 to 20 grams) daily
    children 6 to under 12 years1 to 2 level teaspoons (5 to 10 grams) daily

    Not recomended for children under 6 years of age

  • DOSAGE & ADMINISTRATION

    SORE FEET RELIEF: Add one cup of HealthSmartTM Epsom Salt to one gallon of warm water and soak at least 5 minutes at a time.

    BATH SOAK: Add two cups of HealthSmartTM Epsom salt under warm running bath water to release its gentle aroma. HealthSmartTM Epsom Salt helps relieve tension and provides a soothing, relaxing experience. Soak for at least 20 minutes.

    First Aid Compress: Dissolve 2 cups of HealthSmart TM 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

    Keep out of reach of children Where promt relief is not obtained or where there is evidence of infection, discontinue use and consult a physician. Hot or warm soaks should not be used by individuals with diabetes except on advice of a physician. Avoid contact with eyes.

    EPSOM SALT WITHOUT SCENT CAN BE APPLIED FOR BOTH INTERNAL AND EXTERNAL USE, SCENTED EPSOM SALTS CAN BE APPLIED FOR EXTERNAL USE ONLY.

  • INACTIVE INGREDIENT

    INGREDIENTS: Natural Magnesium Sulfate

  • STORAGE AND HANDLING

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

  • SPL UNCLASSIFIED SECTION

    MADE IN CHINA . DISTRIBUTED BY:
    homesmartTM
    PRODUCTS
    SOUTHFIELD, MI 48075
    WWW.HOMESMARTPRODUCTS.COM
    NDC#52862-200

  • Package Label

    HEALTH
    SMARTTM

    NATURAL
    Epson
    Salt

    Magnesium Sulfate U.S.P
    Soaking Solution
    Saline Laxative

    Soothes Minor Aches, Sprains & Sore Muscles
    Calming & Rejuvenating

    NET WT 16 OZ (454g)

    HS Natural Epsom Salt label
  • INGREDIENTS AND APPEARANCE
    HEALTH SMART NATURAL EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-200
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE1 g  in 1 g
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52862-200-16454 g in 1 CARTON
    2NDC:52862-200-22624 g in 1 CARTON
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/2013
    Labeler - International Wholesale, Inc. (161872676)