Label: THERAWORX RELIEF- magnesium sulfate heptahydrate liquid
- NDC Code(s): 61594-006-03
- 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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- Inactive Ingredients
- Theraworx Relief 3.4oz/101mL (61594-006-03)
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INGREDIENTS AND APPEARANCE
THERAWORX RELIEF
magnesium sulfate heptahydrate liquidProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:61594-006 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 101 mL Inactive Ingredients Ingredient Name Strength WATER (UNII: 059QF0KO0R) COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX) ALOE VERA LEAF (UNII: ZY81Z83H0X) SILVER (UNII: 3M4G523W1G) 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:61594-006-03 101 mL in 1 BOTTLE; Type 0: Not a Combination Product 11/08/2018 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved homeopathic 11/08/2018 Labeler - AVADIM HOLDINGS, INC. (118512488) Establishment Name Address ID/FEI Business Operations AVADIM HOLDINGS, INC. 118512488 manufacture(61594-006)