Theraworx Relief Muscle Cramp And Spasm Relief Spray, Metered
FDA Label NDC 61594-004

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 Muscle Cramp And Spasm Relief (NDC 61594-004). 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 active ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breastfeeding,, keep out of reach of children., 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 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:

Label (Label)

Label (Label)

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