Theraworx Joint Relief Roll On Liquid
FDA Label NDC 61594-027

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 Joint Relief Roll On (NDC 61594-027). 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

Olibanum 8X 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 State.

Purpose

Anti Inflammatory

Uses

  • relieves joint discomfort
  • increase range of motion
  • improves daily function

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 affected area and allow to air dry
  • if applicable put on compression
  • repeat
  • use as needed

Inactive Ingredients (Alphabetical)

Allantoin, Aloe barbadensis Leaf Extract, Aloe barbadensis Leaf Juice, Aqua (Water), Benzyl Alcohol, Calcium Carbonate, Citric Acid, Cocamidopropyl Betaine, Colloidal Silver, Croton Lechieri Resin Extract, Decyl Glucoside, Ethylhexylglycerin, Glycerin, PEG/PPG-4/12 Dimethicone, Parfum (Fragrance), Potassium Sorbate, Sodium Benzoate, Tetrasodium EDTA, Tocopherol Acetate, Vitex Agnus- Castus Extract, Xanthan Gum, Yeast Extract, Yucca shidigera Extract

Package Labeling:

Label (Label)

Label (Label)

* Please review the disclaimer below.