THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL ON- 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 Muscle Cramps Roll On

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, 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:

Label0

THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL ON 
magnesium sulfate, unspecified form aerosol, foam
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-025
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)  
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61594-025-0074 mL in 1 BOTTLE; Type 0: Not a Combination Product04/04/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/04/2022
Labeler - AVADIM HOLDINGS, INC. (118512488)

Revised: 7/2023
Document Id: 004bbcd7-9ac8-5809-e063-6294a90a2526
Set id: 464e8768-fe3f-435b-a8ba-f8567bc1506a
Version: 2
Effective Time: 20230712
 
AVADIM HOLDINGS, INC.