Assured Vaporizing Chest Rub Ointment
FDA Label NDC 33992-7992

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured Vaporizing Chest Rub (NDC 33992-7992). 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, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, inactive ingredient, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active Ingredients

Camphor            4.7%

Eucalyptus Oil    1.2%

Menthol            1.25%

Otc - Purpose

Purpose

Cough Suppressant & Topical analgesic

Cough Suppressant

Cough Suppressant & Topical analgesic

Indications & Usage

Uses

  • use on chest and throat to temporarily relieve cough
  • use on aching muscles to temporarily relieve minor aches and pains

Warnings

Warnings

For external use only; Do not take by mouth or place in nostrils. Avoid excessive heat. Never expose this product to flame or place in any container in which you are heating water. Never place in microwave oven.

Otc - Ask Doctor

Consult a doctor and discontinue use;

If cough persist for more than 1 week, tends to recur or is accompanied by fever, rash or persistent headache.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

In case of accidental ingestion, seek professional assistance or contact a Poison Control Centre immediately.

Dosage & Administration

Directions:

  • Adults and children over 2 years of age; Rub a thick layer on chest and throat to provide temporary relief from nasal congestion and coughing due to colds. If desired, cover with dry, warm cloth, but keep clothing loose to let the vapours rise to nose and mouth. Repeat up to three times daily, especially at bedtime, or as directed by a doctor.
  • Children under two years of age, consult a doctor.

Inactive Ingredient

Inactive Ingredients:

Petrolatum, Mineral Oil, Nutmeg Oil, Spirits of Turpentine, Cedarleaf Oil, Thymol

Package Label.Principal Display Panel

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

Label (Vaporising Chest Rub)

Label (Vaporising Chest Rub)

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