SPL v1
SPL
SPL Set ID 065bb666-e482-4e96-ac75-c6577dcc5b48
Route
TOPICAL
Published
Effective Date 2025-07-25
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-07-25

Description

Camphor 4.7%                                     Cough suppressant & topical analgesic Eucalyptus oil 1.2%                               Cough suppressant Menthol 1.25%                                      Cough suppressant & topical analgesic

Purpose

Camphor 4.7%                                     Cough suppressant & topical analgesic Eucalyptus oil 1.2%                               Cough suppressant Menthol 1.25%                                      Cough suppressant & topical analgesic


Medication Information

Purpose

Camphor 4.7%                                     Cough suppressant & topical analgesic Eucalyptus oil 1.2%                               Cough suppressant Menthol 1.25%                                      Cough suppressant & topical analgesic

Description

Camphor 4.7%                                     Cough suppressant & topical analgesic Eucalyptus oil 1.2%                               Cough suppressant Menthol 1.25%                                      Cough suppressant & topical analgesic

Uses

When applied to chest or throat: Temporarily relieves cough due to minor throat and bronchial irritation associated with a common cold

When applied to muscles and joints: Temporarily relieves minor aches and pains of muscles and joints

Section 50565-1

Section 55105-1

Warnings

For external use only

Ask a doctor before use if you have:

  • A cough with too much phlegm (mucus)
  • Chronic cough that lasts or 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 burns
  • Take by mouth or place in nostrils Use in or near eyes
  • Apply to wounds or damaged skin
  • Bandage tightly
  • Use with other topical pain relievers

Stop Use and Ask a Doctor If

  • Muscle aches and pains worsen or last more than 7 days Symptoms clear up and then return within a few days
  • Cough persists more than 1 week, tends to recur, or is accompanied by: Fever, Rash, Persistent headache A persistent cough may be a sign of a serious condition
  • Redness or irritation develops

If Pregnant or Breast-feeding: Ask a health professional before use.

Keep Out of Reach of Children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

See important warnings under "When using this product" For Cough Suppression:

Adults and children 2 years and older:

▪ Rub on the throat and chest in a thick layer

▪ Cover with a warm, dry cloth if desired

▪ Clothing should be loose around 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 of age:

▪ Ask a doctor

For Muscle & Joint Minor Aches and Pains:

Adults and children 2 years and older:

▪ Clean affected area before applying

▪ Apply to affected area no more than 3 to 4 times daily

Children under 2 years of age:

▪ Consult a doctor

Product Label

Other Information
  • Store at room temperature
Inactive Ingredients

Cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

Active Ingredient                                   purpose

Camphor 4.7%                                     Cough suppressant & topical analgesic

Eucalyptus oil 1.2%                               Cough suppressant

Menthol 1.25%                                      Cough suppressant & topical analgesic


Structured Label Content

Uses

When applied to chest or throat: Temporarily relieves cough due to minor throat and bronchial irritation associated with a common cold

When applied to muscles and joints: Temporarily relieves minor aches and pains of muscles and joints

Section 50565-1 (50565-1)

Section 55105-1 (55105-1)

Warnings

For external use only

Ask a doctor before use if you have:

  • A cough with too much phlegm (mucus)
  • Chronic cough that lasts or 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 burns
  • Take by mouth or place in nostrils Use in or near eyes
  • Apply to wounds or damaged skin
  • Bandage tightly
  • Use with other topical pain relievers

Stop Use and Ask a Doctor If

  • Muscle aches and pains worsen or last more than 7 days Symptoms clear up and then return within a few days
  • Cough persists more than 1 week, tends to recur, or is accompanied by: Fever, Rash, Persistent headache A persistent cough may be a sign of a serious condition
  • Redness or irritation develops

If Pregnant or Breast-feeding: Ask a health professional before use.

Keep Out of Reach of Children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

See important warnings under "When using this product" For Cough Suppression:

Adults and children 2 years and older:

▪ Rub on the throat and chest in a thick layer

▪ Cover with a warm, dry cloth if desired

▪ Clothing should be loose around 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 of age:

▪ Ask a doctor

For Muscle & Joint Minor Aches and Pains:

Adults and children 2 years and older:

▪ Clean affected area before applying

▪ Apply to affected area no more than 3 to 4 times daily

Children under 2 years of age:

▪ Consult a doctor

Product Label (Product label)

Other Information (Other information)
  • Store at room temperature
Inactive Ingredients

Cedar leaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

Active Ingredient                                   purpose (Active Ingredient                                   Purpose)

Camphor 4.7%                                     Cough suppressant & topical analgesic

Eucalyptus oil 1.2%                               Cough suppressant

Menthol 1.25%                                      Cough suppressant & topical analgesic


Advanced Ingredient Data


Raw Label Data

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