Medrox
FDA Label NDC 68258-3984

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Dispensing Solutions, Inc. for the product Medrox (NDC 68258-3984). 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 other, active ingredients, purpose, uses, warnings, keep out of reach of children, directions, other ingredients, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

DRUG FACTS:

Active Ingredients

Methyl Salicylate      20.00%

Menthol                     5.00%

Capsaicin                  0.0375%

Purpose

Analgesic/Counterirritant

Analgesic/Counterirritant

External Analgesic

Uses

Use for the temporary relief of minor aches and muscle pains associated with arthritis, simple backache, strains, muscle soreness and stiffness.

Warnings


  • For external use only. Use only as directed. Avoid contact with eyes and mucous membranes.
  • Do not cover with bandage.
  • Do not use on wounds or damaged skin.

Keep Out Of Reach Of Children

Consult physician for children under 12.


Directions


Apply product directly to affected area. Product may be used as necessary, but should not be used more than four times per day.


Other Ingredients


Deionized Water, Cetyl Alcohol, PEG-150 Distearate, Isopropyl Myristate, Glycerin, Sodium Lauryl Sulfate, Polysorbate-20, Triethanolamine, Acrylates Copolymer, Propylene Glycol, Methyl Paraben, Propyl Paraben, Diazolidinyl Urea, FD and C Blue 1, D and C Yellow 5

Package Label.Principal Display Panel


NDC 68258-3984-04

* Please review the disclaimer below.