THERAWORX RELIEF FOR FOOT CRAMPS FOAM- magnesium sulfate, unspecified form aerosol, foam 
AVADIM HOLDINGS, INC.

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.

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Theraworx Relief for Foot Cramps Foam

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 Homeopathic Pharmacopoeia of the United States.

Purpose

Muscle Soreness Relief

Uses

Warnings

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

When using this product

  • avoid eye contact
  • store between 32ºF and 120ºF
  • ues only as directed 
  • not for ingestion

Stop use and ask a doctor if 

unintended effects occurs.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of chidlren.

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

Directions

Inactive Ingredients (Alphabetical)

Allantoin, Aloe Barbadensis Leaf Extract, Aqua (Water), Beta Glucan, Citrus Grandis (Grapefruit) Seed Extract, Cocamidopropyl Betaine, Colloidal Silver, Glycerin, Lauryl Glucoside, Methylparaben, Parfum (Fragrance), PEG/PPG-4/12 Dimethicone, Propylparaben, Tetrasodium EDTA, Tocopheryl Acetate

Package Labeling:

Label2

THERAWORX RELIEF FOR FOOT CRAMPS FOAM 
magnesium sulfate, unspecified form aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-021
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61594-021-00101 mL in 1 BOTTLE; Type 0: Not a Combination Product02/01/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic02/01/2022
Labeler - AVADIM HOLDINGS, INC. (118512488)
Registrant - AVADIM HOLDINGS, INC. (118512488)
Establishment
NameAddressID/FEIBusiness Operations
AVADIM HOLDINGS, INC.118512488manufacture(61594-021)

Revised: 4/2023
Document Id: fa2372ee-b30f-9ddd-e053-6394a90af5b9
Set id: 2f7fe6b7-deb0-4bf7-a8cb-15ae468512da
Version: 3
Effective Time: 20230425
 
AVADIM HOLDINGS, INC.