THERAWORX RELIEF FOR FOOT CRAMPS ROLL ON- magnesium sulfate cream

Theraworx Relief for Foot Cramps Roll On by

Drug Labeling and Warnings

Theraworx Relief for Foot 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 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

INGREDIENTS AND APPEARANCE

THERAWORX RELIEF FOR FOOT CRAMPS ROLL ON 
magnesium sulfate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 61594-041
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: 61594-041-00	1 in 1 CARTON	04/01/2024
1		74 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		04/01/2024

Labeler - AVADIM HOLDINGS, INC. (118512488)