SPL v2
SPL
SPL Set ID c7cdbf2f-4841-4a7a-9056-6a741abc3133
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
Cedar Leaf Oil Nutmeg Oil Mineral Oil Petrolatum Thymol Turpentine Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2018-06-26

Description

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


Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes.

Indications and Usage

Uses

Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains
Dosage and Administration

Directions

  • see important warnings under "When using this product"
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired, cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.
Description

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

Section 42229-5

Other information

  • Store at room temperature
Section 50565-1

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

Section 50566-9

Stop use and ask a doctor if

  • muscle aches/pain persist more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions.
Section 50567-7

When using this product do not

  • heat
  • microwave
  • use near open flame
  • add to hot water or any container where heating water may cause splattering and result in burns
Section 50569-3

Ask a doctor before use if you have

  • asthama
  • excessive phlegm (mucus)
  • emphysema
  • persistent or chronic cough
  • cough associated with smoking
Section 50570-1

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with tight bandages
Section 51727-6

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

Section 51945-4

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

Section 53414-9

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1

Purpose

Cough suppressant/topical analgesic

Cough suppressant/topical analgesic

Cough suppressant

Section 55106-9

Active ingredients

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil     1.2%


Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains
Dosage and Administration (34068-7)

Directions

  • see important warnings under "When using this product"
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired, cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.
Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes.

Section 42229-5 (42229-5)

Other information

  • Store at room temperature
Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • muscle aches/pain persist more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions.
Section 50567-7 (50567-7)

When using this product do not

  • heat
  • microwave
  • use near open flame
  • add to hot water or any container where heating water may cause splattering and result in burns
Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • asthama
  • excessive phlegm (mucus)
  • emphysema
  • persistent or chronic cough
  • cough associated with smoking
Section 50570-1 (50570-1)

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with tight bandages
Section 51727-6 (51727-6)

Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB

Section 53414-9 (53414-9)

If pregnant or breast feeding, ask a health professional before use.

Section 55105-1 (55105-1)

Purpose

Cough suppressant/topical analgesic

Cough suppressant/topical analgesic

Cough suppressant

Section 55106-9 (55106-9)

Active ingredients

Camphor            4.7%

Menthol             1.25%

Eucalyptus Oil     1.2%


Advanced Ingredient Data


Raw Label Data

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