Miracle Rub
FDA Label NDC 66391-1603

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Winning Solutions for the product Miracle Rub (NDC 66391-1603). 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 otc - active ingredient, otc - purpose, warnings, otc - keep out of reach of children, dosage & administration, indications & usage, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredient : Menthol 2.5%

                          Methylsalieylate 10.0%

Otc - Purpose

Purpose : External Analgesic


Warnings

Warnings: For external use only .

Otc - Keep Out Of Reach Of Children

Keep out of reach of children : In case of accidental ingestion, get medical help or contact a Poison Control center right away.


Dosage & Administration

Directions :  adults and  children 12 years and older apply to affected area no more than 3 to 4 times daily

                  under 12 years ask a doctor before use

Indications & Usage

Uses: Temporarly relieves minor aches and pains of muscles and joints due to

  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises

Inactive Ingredient

aloe barabardensis leaf Juice, water, stearic acid, cetyl alcohol, glyceryl stearate, PEG-100 stearte, petrolatum, dimethicone, triethanolamine, eucalyptus globulus leaf oil, imidazolidinyl urea, methylparaben, propylparaben

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