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 July 15, 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

  • Uses

    Internal

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

    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 a Poison Control Center immedietly.

  • 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

    For external use as a soaking solution:

    Add two cups to warm bath water and soak for 20 minutes.

    For external use as a compress:

    Adults dissolve 1 cup Epsom Salt in a quart of warm water, soak towel in solution and apply to affected area for 15 to 30 minutes.

  • Other Information

    • dissolve well before use
    • magnesium content 495 mg per teaspoon (5 grams)
  • Fertilizer Uses - Guaranteed Analysis

    Magnesium (Mg)..................9.87% Water Soluble Magnesium (Mg)

    Sulfer(S).................................................12.98%Combined Sulfer(S)

    Directions for use (Fertilizer)

    Lawns: Apply at a rate of 1/2 pound per one thousand square feet of lawn.

    Garden Plants & Shrubbery: 2 tablespoons around the plant base every 2-4 weeks.

    Trees: 2 tablespoons over the root zone every 4 months.

    Tomatoes: 1 teaspoon per foot plant height every 2 weeks.

    Evergreen, Azaleas & Rhododendrons: 1 tablespoon over root zone every 2-4 weeks.

    Garden Startup: Mix 1 cup per 100 sq. ft of soil prior to planting.

    Houseplants: 1 teaspoon per gallon of water and feed plants every 1-4 weeks.

    An Epsom Salt bath or soak has been trusted as a natural remedy for minor aches and sprains for hundreds of years. Epsom Salt can help relieve tired, achy muscles by providing Magnesium to help reduce swelling, and Sulfate which helps flush toxins from proteins in joints. Epsom Salt can also be consumed as a natural saline laxative for occassional relief.

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

  • SPL UNCLASSIFIED SECTION

    MADE IN CHINA . DISTRIBUTED BY:
    homesmartTM
    PRODUCTS
    SOUTHFIELD, MI 48075
    WWW.HOMESMARTPRODUCTS.COM
    NDC#52862-201

  • INACTIVE INGREDIENT

  • Package Label

    HEALTH
    SMARTTM

    NATURAL
    Epson Salt

    Magnesium Sulfate U.S.P • Soaking Solution • Saline Laxative

    Soothes Minor Aches,
    Sprains & Sore Muscles
    Calming & Rejuvenating

    Original

    NET WT 16 OZ (454g)

    HS Natural Epsom Salt  Original label
  • INGREDIENTS AND APPEARANCE
    HEALTH SMART NATURAL EPSOM SALT 
    magnesium sulfate granule, for solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52862-201
    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:52862-201-16454 g in 1 POUCH
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart33408/01/2013
    Labeler - International Wholesale, Inc. (161872676)