THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF- magnesium sulfate heptahydrate aerosol, foam 
Avadim Technologies, 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 Muscle Cramp and Spasm Relief 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 • do not store at temperature above 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 • apply 2 pumps onto entire muscle group(s) or area • briskly rub in until absorbed •  use as needed • allow to air dry

Inactive Ingredients

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

Package Labeling:

Label2

THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF 
magnesium sulfate heptahydrate aerosol, foam
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:61594-003
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 210 mL
Inactive Ingredients
Ingredient Name Strength
WATER (UNII: 059QF0KO0R)  
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)  
ALOE VERA LEAF (UNII: ZY81Z83H0X)  
SILVER (UNII: 3M4G523W1G)  
.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
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:61594-003-00 210 mL in 1 BOTTLE; Type 0: Not a Combination Product 07/22/2017
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved homeopathic 07/22/2017
Labeler - Avadim Technologies, Inc (041443877)
Registrant - Avadim Technologies, Inc (041443877)

Revised: 12/2017
Document Id: 60e25b7e-0742-5dfb-e053-2a91aa0a5035
Set id: d87274cf-97b5-4965-9187-caec621e6177
Version: 2
Effective Time: 20171221
 
Avadim Technologies, Inc