Theraworx Relief For Foot Cramps Roll On Cream
FDA Label NDC 61594-041
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Avadim Holdings, Inc. for the product Theraworx Relief For Foot Cramps Roll On (NDC 61594-041). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
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
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