SPL v1
SPL
SPL Set ID b8f0c61e-83b0-4835-b950-2c5dcce5cf17
Route
TOPICAL
Published
Effective Date 2019-01-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4.7 g) Eucalyptus Oil (1.2 g) Menthol (1.25 g)
Inactive Ingredients
Petrolatum Mineral Oil Nutmeg Oil Turpentine Oil Cedar Leaf Oil Thymol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2019-01-18

Description

Active Ingredients Camphor            4.7% Eucalyptus Oil    1.2% Menthol            1.25%


Medication Information

Warnings and Precautions

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.

Indications and Usage

Uses

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

Active Ingredients Camphor            4.7% Eucalyptus Oil    1.2% Menthol            1.25%

Section 50565-1

Keep out of reach of children

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

Section 50569-3

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.

Section 51727-6

Inactive Ingredients:

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

Section 51945-4

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

Section 55105-1

Purpose

Cough Suppressant & Topical analgesic

Cough Suppressant

Cough Suppressant & Topical analgesic

Section 55106-9

Active Ingredients

Camphor            4.7%

Eucalyptus Oil    1.2%

Menthol            1.25%


Structured Label Content

Indications and Usage (34067-9)

Uses

  • use on chest and throat to temporarily relieve cough
  • use on aching muscles to temporarily relieve minor aches and pains
Dosage and Administration (34068-7)

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.
Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50569-3 (50569-3)

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.

Section 51727-6 (51727-6)

Inactive Ingredients:

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

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

Section 55105-1 (55105-1)

Purpose

Cough Suppressant & Topical analgesic

Cough Suppressant

Cough Suppressant & Topical analgesic

Section 55106-9 (55106-9)

Active Ingredients

Camphor            4.7%

Eucalyptus Oil    1.2%

Menthol            1.25%


Advanced Ingredient Data


Raw Label Data

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