Theraworx Relief For Muscle Cramps Roll On Aerosol, Foam
FDA Label NDC 61594-025

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 Muscle Cramps Roll On (NDC 61594-025). 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

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 sorenss

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
  • ues only as directed 
  • not for ingestion

Stop Use And Ask A Doctor If

unintended effects occurs.

If Pregnant Or Breastfeeding,

ask a health professional before use.

Keep Out Of Reach Of Chidlren.

If swallowed, get medical help or contact a Poison Control right away.

Directions

  • shake well 
  • roll a thin 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

Package Labeling:

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