Label: THERAWORX RELIEF FOR FOOT CRAMPS ROLL ON- magnesium sulfate cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved homeopathic

DISCLAIMER: This homeopathic product has not been evaluated by the Food and Drug Administration for safety or efficacy. FDA is not aware of scientific evidence to support homeopathy as effective.

Drug Label Information

Updated January 23, 2024

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  • Drug Facts

  • Active Ingredient

    Contains Magnesium Sulfate (Magnesia sulphurica) 6X 0.05% HPUS The letters H.P.U.S. indicate that the components in this product are officially monographed in the Homepathic Pharmacopoeia of the United States.

    Purpose

    Muscle Soreness Relief

  • Uses

    • prevents cramps and spasms • releases muscle tightness • relieves muscle soreness

  • Warnings

    For external use only. If eye contact occurs, rinse thoroughly with water.

    When using this product

    • avoid eye contact • store between 32°F and 120°F • use only as directed • not for ingestion

    Stop use and ask a doctor if

    unintended effects occur.

    If pregnant or breastfeeding,

    ask a health professional before use.

    Keep out of reach of children.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • shake well • roll a thin layer to each impacted muscle group and allow to air dry • repeat • use as needed

  • Inactive Ingredients (Alphabetical)

    Allantoin, Aloe Barbadensis Leaf Extract, Aloe Barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopheryl Acetate, Xanthan Gum, Yeast Extract

  • Label

    label 2.jpg

  • INGREDIENTS AND APPEARANCE
    THERAWORX RELIEF FOR FOOT CRAMPS ROLL ON 
    magnesium sulfate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-041
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM6 [hp_X]  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    ALLANTOIN (UNII: 344S277G0Z)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    WATER (UNII: 059QF0KO0R)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
    SILVER (UNII: 3M4G523W1G)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61594-041-001 in 1 CARTON04/01/2024
    174 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved homeopathic04/01/2024
    Labeler - AVADIM HOLDINGS, INC. (118512488)
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