Label: EPSOM SALT SOAKING SOLUTION- magnesium sulfate granule

  • NDC Code(s): 51345-099-01
  • Packager: Advanced Beauty Systems, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 06/12

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

  • ACTIVE INGREDIENT

    Active ingredient                                     Purpose

    Magnesium Sulfate USP (Epsom Salts)     

    External use                                          Soaking solution

    Internal Use                                           Saline Laxative     

    Uses

    External: Relieves pain from minor sprains and bruises

    Internal: Relieves occasional constipation (irregularity)

    generally produces bowel movement in 1/2 to 6 hours.

    Keep out of reach of children. In case of accidental ingestion or overdose, seek medical attention or contact a Poison Control Center immediately.

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

    Stop use and consult a doctor if:

    As a soaking solution

    - you experience redness, irritation, swelling , or infection

    As a laxative

    - you have no bowel movements within six hours or experience rectal bleeding-these could be signs of a serious condition

    - you need a laxative for more than a week

    Warnings:

    Laxative
    - Do not give to children under six years of age except under the advice and supervision of a physician.
    - For occasional use only. Serious side effects from prolonged use or overdose may occur.

    Do not take this product except under the advice and supervision of a physician if you:
    - Have kidney disease
    - Are taking prescription medication
    - Have a magnesium restricted diet

    Ask a doctor before if you have

    As a soaking solution
    - redness or swelling present
    - evidence of an infection
    - diabetes - hot and warm soaks should not be used by individuals with diabetes except on advice of a physician

    As a laxative
    - Stomach pain
    - Nausea
    - Kidney disease
    - A sudden change in bowel habits that lasts over 2 weeks

    If pregnant or breast feeding, consult a physician before use

    Other information
    Dissolve before use

    Directions

    - Do not exceed more than 2 doses per day, if neccessary repeat dosage in 4 hours

    For External use

    As a soaking solution: pour 2 cups of Epsom Salts under warm, running bath water. Soak for 20 minutes for to relieve sore,tired muscles.

    As a warm compress: Dissolve 1 cup of Epsom Salts in 1 quart of warm water. Using a towel, apply solution to the affected area for 15-30  minutes to reduce pain and and swelling. Repeat as needed.


    For internal use

    As a laxative                                             2-4 level teaspoons dissolved in a full glass (8oz) of water.
    adults and children 12 years and older

    children 6 to 12 years of age                      1-2 level teaspoons dissolved in a full glass (8oz) of water.

    not recommended for children under 6 years of age

    This product contains no inactive ingredients




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  • PRINCIPAL DISPLAY PANEL

    Dr. Teal's


    Therapeutic solutions

    Epsom Salt Soaking Solution

    Magnesium Sulfate USP

    Sooths aches, pains, sprains and stings

    Helps relieve muscle tension

    Made in U.S.A. with pure Epsom Salt


    Net Wt. 2.72 Kg   6 lbs






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  • INGREDIENTS AND APPEARANCE
    EPSOM SALT  SOAKING SOLUTION
    magnesium sulfate granule
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:51345-099
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MAGNESIUM SULFATE (MAGNESIUM CATION) MAGNESIUM SULFATE 2.72 kg  in 2.72 kg
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51345-099-01 2.72 kg in 1 BAG
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part334 06/13/2012
    Labeler - Advanced Beauty Systems, Inc. (129986613)
    Registrant - Giles Chemical, a division of Premier Magnesia, LLC (003162435)
    Establishment
    Name Address ID/FEI Business Operations
    Giles Chemical, a division of Premier Magnesia, LLC 003162435 manufacture
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