Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID f4675bc1-01cc-4a33-a3bf-bfc99230fe32
Route
TOPICAL
Published
Effective Date 2022-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (53 mg) Eucalyptus Oil (13 mg) Menthol, Unspecified Form (28 mg)
Inactive Ingredients
Glyceryl Dibehenate Light Mineral Oil Octyldodecyl Oleate Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2016-07-01

Description

Camphor 5.3% Eucalyptus oil 1.3% Menthol 2.8%

Purpose

Camphor - Cough suppressant / topical analgesic Eucalyptus oil - Cough suppressant Menthol - Cough suppressant / topical analgesic


Medication Information

Purpose

Camphor - Cough suppressant / topical analgesic

Eucalyptus oil - Cough suppressant

Menthol - Cough suppressant / topical analgesic

Description

Camphor 5.3% Eucalyptus oil 1.3% Menthol 2.8%

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • temporarily relieves cough to help you sleep
  • temporarily relieves minor aches and pains of muscles and joints
Warnings

For external use only

Directions
  • see important warnings under "When using this product"
  • adults and children 2 years and over:
    • roll on a thick layer on the throat and chest for cough, or on sore aching muscles or joints
    • cover with a warm, dry cloth if desired
    • clothing should be left loose about the throat and chest to help vapors reach the nose and mouth
    • use up to 3 times daily, or as directed by a doctor
  • children under 2 years: ask a doctor
Questions?

1-877-636-2677 MON-FRI 9AM to 5 PM (EST)

Active Ingredients

Camphor 5.3%

Eucalyptus oil 1.3%

Menthol 2.8%

Inactive Ingredients

fragrance, glyceryl dibehenate, light mineral oil, octyldodecyl olivate, petrolatum

When Using This Product
  • do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns
  • do not take by mouth or place in nostrils
  • do not bandage tightly
  • do not get into eyes
  • do not apply to wounds or damaged skin
Stop Use and Ask A Doctor If
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • muscle aches and pains persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts or as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel

Structured Label Content

Uses
  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • temporarily relieves cough to help you sleep
  • temporarily relieves minor aches and pains of muscles and joints
Purpose

Camphor - Cough suppressant / topical analgesic

Eucalyptus oil - Cough suppressant

Menthol - Cough suppressant / topical analgesic

Warnings

For external use only

Directions
  • see important warnings under "When using this product"
  • adults and children 2 years and over:
    • roll on a thick layer on the throat and chest for cough, or on sore aching muscles or joints
    • cover with a warm, dry cloth if desired
    • clothing should be left loose about the throat and chest to help vapors reach the nose and mouth
    • use up to 3 times daily, or as directed by a doctor
  • children under 2 years: ask a doctor
Questions?

1-877-636-2677 MON-FRI 9AM to 5 PM (EST)

Active Ingredients (Active ingredients)

Camphor 5.3%

Eucalyptus oil 1.3%

Menthol 2.8%

Inactive Ingredients (Inactive ingredients)

fragrance, glyceryl dibehenate, light mineral oil, octyldodecyl olivate, petrolatum

When Using This Product (When using this product)
  • do not heat, microwave, or add to hot water or any container where heating water. May cause splattering and result in burns
  • do not take by mouth or place in nostrils
  • do not bandage tightly
  • do not get into eyes
  • do not apply to wounds or damaged skin
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition.
  • muscle aches and pains persist for more than 7 days or clear up and occur again within a few days
Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • cough that occurs with too much phlegm (mucus)
  • chronic cough that lasts or as occurs with smoking, asthma, or emphysema
Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data


Raw Label Data

All Sections (JSON)