Label: THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL ON- magnesium sulfate, unspecified form aerosol, foam
- NDC Code(s): 61594-025-00
- 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 July 12, 2023
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Drug Facts
- Active Ingredient
- Uses
- Warnings
- Directions
-
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
- Package Labeling:
-
INGREDIENTS AND APPEARANCE
THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL ON
magnesium sulfate, unspecified form aerosol, foamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61594-025 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) 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:61594-025-00 74 mL in 1 BOTTLE; Type 0: Not a Combination Product 04/04/2022 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 04/04/2022 Labeler - AVADIM HOLDINGS, INC. (118512488)