Label: THERAWORX RELIEF FOR FOOT CRAMPS FOAM- magnesium sulfate, unspecified form aerosol, foam
- NDC Code(s): 61594-021-00
- 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 25, 2023
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INGREDIENTS AND APPEARANCE
THERAWORX RELIEF FOR FOOT CRAMPS FOAM
magnesium sulfate, unspecified form aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61594-021 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED FORM 6 [hp_X] in 1 mL Inactive Ingredients Ingredient Name Strength ALLANTOIN (UNII: 344S277G0Z) ALOE VERA LEAF (UNII: ZY81Z83H0X) WATER (UNII: 059QF0KO0R) CITRUS MAXIMA SEED (UNII: 083X55C543) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) SILVER (UNII: 3M4G523W1G) GLYCERIN (UNII: PDC6A3C0OX) LAURYL GLUCOSIDE (UNII: 76LN7P7UCU) METHYLPARABEN (UNII: A2I8C7HI9T) PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85) PROPYLPARABEN (UNII: Z8IX2SC1OH) EDETATE SODIUM (UNII: MP1J8420LU) .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:61594-021-00 101 mL in 1 BOTTLE; Type 0: Not a Combination Product 02/01/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 02/01/2022 Labeler - AVADIM HOLDINGS, INC. (118512488) Registrant - AVADIM HOLDINGS, INC. (118512488) Establishment Name Address ID/FEI Business Operations AVADIM HOLDINGS, INC. 118512488 manufacture(61594-021)