SPL v10
SPL
SPL Set ID 4cd2f751-e072-4f4e-b059-ed1dfcc60c6b
Route
TOPICAL
Published
Effective Date 2024-06-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (0.048 g) Menthol (0.026 g) Eucalyptus Oil (0.012 g)
Inactive Ingredients
Cedar Leaf Oil Nutmeg Oil Paraffin Petrolatum Thymol Turpentine Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Completed Since 2014-07-09 Until 2017-07-01

Description

Camphor 4.8% Menthol 2.6% Eucalyptus oil 1.2%


Medication Information

Warnings and Precautions

For external use only. Avoid contact with eyes.

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with tight bandages

Ask a doctor before use if you have

  • cough is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

When using this product do not

  • heat
  • microwave
  • add to hot water or any container where heating water.  May cause splattering and result in burns

Stop use and ask a doctor if

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

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

Indications and Usage
  • When applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold
  • On muscles and joints, temporarily relieves minor aches and pains
Dosage and Administration

See important warnings under "When using this product"

  • Adults and children 2 years of age and older
  • for cough suppressent:
  • rub on throat and chest in thick layer
  • cover with a warm, dry cloth if desired
  • clothing shoudl be loose about throat and chest to help vapors reach the nose and mouth
  • use up to three times daily or as directed by doctor
  • for minor ache and pains in muscle and joints:
  • apply to affecteed area not more than 3 to 4 times daily
  • Children under 2 years of age:do not use, consult a doctor
Description

Camphor 4.8% Menthol 2.6% Eucalyptus oil 1.2%

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6

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

Section 51945-4

Section 55105-1

Camphor: cough suppressant / topical analgesic

Menthol: cough suppressant / topical analgesic

Eucalyptus oil: cough suppressant

Section 55106-9

Camphor 4.8%

Menthol 2.6%

Eucalyptus oil 1.2%

Section 60561-8

Store at room temperature


Structured Label Content

Indications and Usage (34067-9)
  • When applied to chest and throat, temporarily relieves cough due to minor throat and bronchial irritations associated with the common cold
  • On muscles and joints, temporarily relieves minor aches and pains
Dosage and Administration (34068-7)

See important warnings under "When using this product"

  • Adults and children 2 years of age and older
  • for cough suppressent:
  • rub on throat and chest in thick layer
  • cover with a warm, dry cloth if desired
  • clothing shoudl be loose about throat and chest to help vapors reach the nose and mouth
  • use up to three times daily or as directed by doctor
  • for minor ache and pains in muscle and joints:
  • apply to affecteed area not more than 3 to 4 times daily
  • Children under 2 years of age:do not use, consult a doctor
Warnings and Precautions (34071-1)

For external use only. Avoid contact with eyes.

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with tight bandages

Ask a doctor before use if you have

  • cough is accompanied by excessive phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

When using this product do not

  • heat
  • microwave
  • add to hot water or any container where heating water.  May cause splattering and result in burns

Stop use and ask a doctor if

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

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

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away

Section 51727-6 (51727-6)

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

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Camphor: cough suppressant / topical analgesic

Menthol: cough suppressant / topical analgesic

Eucalyptus oil: cough suppressant

Section 55106-9 (55106-9)

Camphor 4.8%

Menthol 2.6%

Eucalyptus oil 1.2%

Section 60561-8 (60561-8)

Store at room temperature


Advanced Ingredient Data


Raw Label Data

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