Label: THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF- magnesium sulfate heptahydrate aerosol, foam
- NDC Code(s): 61594-003-00
- Packager: AVADIM HOLDINGS, INC.
- 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 April 24, 2023
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INGREDIENTS AND APPEARANCE
THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF
magnesium sulfate heptahydrate aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61594-003 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE HEPTAHYDRATE 6 [hp_X] in 210 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ALOE VERA LEAF (UNII: ZY81Z83H0X) SILVER (UNII: 3M4G523W1G) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) GLYCERIN (UNII: PDC6A3C0OX) ALLANTOIN (UNII: 344S277G0Z) GRAPEFRUIT (UNII: O82C39RR8C) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) EDETATE SODIUM (UNII: MP1J8420LU) PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85) METHYLPARABEN (UNII: A2I8C7HI9T) PROPYLPARABEN (UNII: Z8IX2SC1OH) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61594-003-00 210 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/2017 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 07/22/2017 Labeler - AVADIM HOLDINGS, INC. (118512488) Registrant - AVADIM HOLDINGS, INC. (118512488)