Vaporizing Chest Rub
FDA Label NDC 50438-502

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Filo America for the product Vaporizing Chest Rub (NDC 50438-502). 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 use, warnings, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, directions, inactive ingredients, principal display panel - 100g jar label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Use

when applied to chest and throat

  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • when applied to muscles and joints

    • temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only; avoid contact with eyes.

Ask A Doctor Before Use If You Have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma, or emphysema

When Using This Product

  • do not heat
  • do not microwave
  • do not add to hot water or any container where heating water. May cause splattering and result in burns.
  • do not take by mouth or place in nostrils

Stop Use And Ask A Doctor If

  • cough persists for more than 1 week, tends to recur or is accompanied by fever, rash, or persistent cough may be a sign of a serious condition.
  • muscle aches and pains worsen, persist for more than 7 days, or clear up occur again within a few days.

Directions

  • see important warnings under "When using this product"
  • adults and children 2 year and over.
  • for cough suppression

    • rub a thick layer on the throat and chest
    • cover with a warm, dry cloth if desired
    • keep clothing loose about throat and chest to help vapors reach the nose and mouth
    • use up to 3 times daily, or as directed by a doctor
    • for muscle/joint minor aches and pains apply

      • to affected area not more than 3-4 times daily
      • children under 2 yeas : ask a doctor
      • other information

        • store at room temperature
        • if pregnant or breast feeding

          • ask a health professional before use

Inactive Ingredients

Cedar leaf oil, methylparaben, Nutmeg oil, petrolatum, Turpentine oil, Thymol, propylparaben

Principal Display Panel - 100G Jar Label

VAPORIZING
CHEST RUB

4 oz (113g)

* Please review the disclaimer below.