THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF- magnesium sulfate heptahydrate spray, metered

Theraworx Relief Muscle Cramp and Spasm Relief by

Drug Labeling and Warnings

Theraworx Relief Muscle Cramp and Spasm Relief 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 muscle cramps
• releases muscle tightness
• reduces muscle soreness

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 6–8 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:

INGREDIENTS AND APPEARANCE

THERAWORX RELIEF MUSCLE CRAMP AND SPASM RELIEF 
magnesium sulfate heptahydrate spray, metered

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-004
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: 61594-004-00	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 Health, Inc. (041443877)

Registrant - Avadim Health, Inc. (041443877)