THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL-ON- magnesium sulfate, unspecified form aerosol

Theraworx Relief for Muscle Cramps Roll-On by

Drug Labeling and Warnings

Theraworx Relief for Muscle Cramps Roll-On 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 componets in this product are officially monograped 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

SPL UNCLASSIFIED SECTION

Store between 32°F and 120°F

Package Labeling:

INGREDIENTS AND APPEARANCE

THERAWORX RELIEF FOR MUSCLE CRAMPS ROLL-ON 
magnesium sulfate, unspecified form aerosol

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-046
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
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 61594-046-00	1 in 1 CARTON	01/01/2025
1		89 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		01/01/2025

Labeler - AVADIM HOLDINGS, INC. (118512488)

Establishment
Name	Address	ID/FEI	Business Operations
AVADIM HOLDINGS, INC.		118512488	manufacture(61594-046)