SPL v6
SPL
SPL Set ID 8e6f731f-c16a-41b2-9786-0cab588cfc8e
Route
TOPICAL
Published
Effective Date 2009-10-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4.7 g) Menthol (1 g) Eucalyptus Oil
Inactive Ingredients
Cedar Leaf Oil Nutmeg Paraffin Petrolatum Thymol Turpentine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2009-11-15

Description

Camphor 4.7% Menthol 1.0% Eucalyptus Oil 1.0%

Purpose

Cough Suppressant Nasal Decongestant Topical Anlagesic


Medication Information

Purpose

Cough Suppressant

Nasal Decongestant

Topical Anlagesic

Description

Camphor 4.7% Menthol 1.0% Eucalyptus Oil 1.0%

Uses

Temporarily relieves symptoms associated with the common cold:

  • cough
  • nasal congestion
  • chest congestion

Temporarily relieves minor aches and pains of muscles

Warnings

For external use only. Avoid contact with eyes.

Directions

See important warnings under "Do not Use this product"

  • Children under 2 years of age, ask a doctor
  • Adults and children 2 years of age and older: rub a thick layer on chest and throat. If desired loosely cover with a soft cloth but keep clothing loose.
  • Repeat up to 3 times daily, or as directed by a doctor

Package Label

Active Ingredients

Camphor 4.7%

Menthol 1.0%

Eucalyptus Oil 1.0%



Inactive Ingredients

Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Paraffin

Do Not Use This Product

Near an open flame. By adding water. By mouth. In a microwave oven. On wounds or damaged skin. With tight bandages. In nostrils. added to hot water or any container where you are heating water. May cause splattering and result in burns.

Stop Use and Ask A Doctor

if Muscle aches and pains persist for more than 7 days comes back, or occurs with fever, rash or headache that lasts.

These could be signs of a serious condition. If pregnant or breast-feeding consult a physician before use.

Keep Out of Reach of Children

If swallowed get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have

Chronic cough that lasts or occurs with smoking, asthma or emphysema.

Cough with excessive phlegm (mucus).


Structured Label Content

Uses

Temporarily relieves symptoms associated with the common cold:

  • cough
  • nasal congestion
  • chest congestion

Temporarily relieves minor aches and pains of muscles

Purpose

Cough Suppressant

Nasal Decongestant

Topical Anlagesic

Warnings

For external use only. Avoid contact with eyes.

Directions

See important warnings under "Do not Use this product"

  • Children under 2 years of age, ask a doctor
  • Adults and children 2 years of age and older: rub a thick layer on chest and throat. If desired loosely cover with a soft cloth but keep clothing loose.
  • Repeat up to 3 times daily, or as directed by a doctor

Package Label

Active Ingredients

Camphor 4.7%

Menthol 1.0%

Eucalyptus Oil 1.0%



Inactive Ingredients

Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Paraffin

Do Not Use This Product (Do not use this product)

Near an open flame. By adding water. By mouth. In a microwave oven. On wounds or damaged skin. With tight bandages. In nostrils. added to hot water or any container where you are heating water. May cause splattering and result in burns.

Stop Use and Ask A Doctor (Stop use and ask a doctor)

if Muscle aches and pains persist for more than 7 days comes back, or occurs with fever, rash or headache that lasts.

These could be signs of a serious condition. If pregnant or breast-feeding consult a physician before use.

Keep Out of Reach of Children (Keep out of reach of children)

If swallowed get medical help or contact a Poison Control Center immediately.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

Chronic cough that lasts or occurs with smoking, asthma or emphysema.

Cough with excessive phlegm (mucus).


Advanced Ingredient Data


Raw Label Data

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