THERAWORX RELIEF FOR FOOT CRAMPS ROLL ON- magnesium sulfate cream 
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 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 Homepathic Pharmacopoeia of the United States.

Purpose

Muscle Soreness Relief

Uses

• prevents cramps and spasms • releases muscle tightness • relieves muscle soreness

Warnings

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

When using this product

• avoid eye contact • store between 32°F and 120°F • use only as directed • not for ingestion

Stop use and ask a doctor if

unintended effects occur.

If pregnant or breastfeeding,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• shake well • roll a thin layer to each impacted muscle group and allow to air dry • repeat • use as needed

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

Label

label 2.jpg

THERAWORX RELIEF FOR FOOT CRAMPS ROLL ON 
magnesium sulfate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61594-041
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:61594-041-001 in 1 CARTON04/01/2024
174 mL in 1 BOTTLE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved homeopathic04/01/2024
Labeler - AVADIM HOLDINGS, INC. (118512488)

Revised: 1/2024
Document Id: 0f9f1480-ad81-d59b-e063-6394a90ad5ab
Set id: 21b58f2e-f4e0-4506-9e72-54a58d3f3617
Version: 1
Effective Time: 20240123
 
AVADIM HOLDINGS, INC.