THERAWORX RELIEF FOR MUSCLE CRAMPS- magnesium sulfate, unspecified form spray

Theraworx Relief for Muscle Cramps by

Drug Labeling and Warnings

Theraworx Relief for Muscle Cramps by is a Homeopathic medication manufactured, distributed, or labeled by AVADIM HOLDINGS, INC.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

• 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
• apply 6–8 pumps to each impacted muscle group
• rub in briskly until absorbed
• repeat
• allow to air dry
• use as needed

Inactive Ingredients (Alphabetical)

Allantoin, Aloe barbadensis Leaf Juice, Aloe barbadensis Leaf Extract, Aqua (Water), Benzyl Alcohol, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Decyl Glucoside, Ethylhexylglycerin, Glycerin, PEG/PPG-4/12 Dimethicone, Parfum (Fragrance), Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopherol, Yeast Extract

SPL UNCLASSIFIED SECTION

Store between 32°F and 120°F

Package Labeling:

INGREDIENTS AND APPEARANCE

THERAWORX RELIEF FOR MUSCLE CRAMPS 
magnesium sulfate, unspecified form spray

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-026
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MAGNESIUM SULFATE, UNSPECIFIED FORM (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM SULFATE, UNSPECIFIED FORM	6 [hp_X]  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
SILVER (UNII: 3M4G523W1G)
DECYL GLUCOSIDE (UNII: Z17H97EA6Y)
ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)
GLYCERIN (UNII: PDC6A3C0OX)
PEG/PPG-4/12 DIMETHICONE (UNII: JAN3585W85)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
SODIUM BENZOATE (UNII: OJ245FE5EU)
EDETATE SODIUM (UNII: MP1J8420LU)
TOCOPHEROL (UNII: R0ZB2556P8)
YEAST, UNSPECIFIED (UNII: 3NY3SM6B8U)
ALLANTOIN (UNII: 344S277G0Z)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
WATER (UNII: 059QF0KO0R)
BENZYL ALCOHOL (UNII: LKG8494WBH)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61594-026-00	1 in 1 CARTON	08/02/2023
1		50 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved homeopathic		08/02/2023

Labeler - AVADIM HOLDINGS, INC. (118512488)