Drug Facts

SPL v10

SPL

SPL Set ID 3006971b-784c-43fd-91a6-d96876bbf185

Route

TOPICAL

Published

Effective Date 2024-12-15

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Camphor (synthetic) (48 mg) Eucalyptus Oil (12 mg) Menthol (26 mg)

Inactive Ingredients

Turpentine Petrolatum Thymol

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2007-01-12

Description

Camphor 4.8% Eucalyptus oil 1.2% Menthol 2.6%

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 4.8% Eucalyptus oil 1.2% Menthol 2.6%

Uses

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only

Directions

see important warning under "When using this product"
adults and children 2 years and over:
rub a thick layer on the throat and chest for cough, or rub on sore aching muscles and 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?

Call: 1-888-287-1915

Active Ingredients

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Inactive Ingredients

fragrance, thymol, turpentine oil, white petrolatum

When Using This Product

do not heat
do not microwave
do not 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 get into eyes
do not apply to wounds or damaged skin
do not bandage tightly

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 worsen, persist for more than 7 days, or clear up and occur again within a few days

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.

Ask A Doctor Before Use If You Have

cough that occurs with too much phlegm (mucus)
chronic cough that lasts or 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 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 warning under "When using this product"
adults and children 2 years and over:
rub a thick layer on the throat and chest for cough, or rub on sore aching muscles and 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?

Call: 1-888-287-1915

Active Ingredients (Active ingredients)

Camphor 4.8%

Eucalyptus oil 1.2%

Menthol 2.6%

Inactive Ingredients (Inactive ingredients)

fragrance, thymol, turpentine oil, white petrolatum

When Using This Product (When using this product)

do not heat
do not microwave
do not 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 get into eyes
do not apply to wounds or damaged skin
do not bandage tightly

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 worsen, persist for more than 7 days, or clear up and occur again within a few days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional 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 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 occurs with smoking, asthma, or emphysema

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Advanced Ingredient Data

[{"name": "TURPENTINE", "unii": "XJ6RUH0O4G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PETROLATUM", "unii": "4T6H12BN9U", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "CAMPHOR (SYNTHETIC)", "unii": "5TJD82A1ET", "classCode": "ACTIB", "strengthNumerator": "48", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "EUCALYPTUS OIL", "unii": "2R04ONI662", "classCode": "ACTIB", "strengthNumerator": "12", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "MENTHOL", "unii": "L7T10EIP3A", "classCode": "ACTIB", "strengthNumerator": "26", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "THYMOL", "unii": "3J50XA376E", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "temporarily relieves cough due to minor throat and bronchial irritation associated with a cold 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 warning under "When using this product" adults and children 2 years and over: rub a thick layer on the throat and chest for cough, or rub on sore aching muscles and 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?": "Call: 1-888-287-1915", "Active ingredients": "Camphor 4.8% Eucalyptus oil 1.2% Menthol 2.6%", "Inactive ingredients": "fragrance, thymol, turpentine oil, white petrolatum", "When using this product": "do not heat do not microwave do not 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 get into eyes do not apply to wounds or damaged skin do not bandage tightly", "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 worsen, persist for more than 7 days, or clear up and occur again within a few days", "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.", "Ask a doctor before use if you have": "cough that occurs with too much phlegm (mucus) chronic cough that lasts or occurs with smoking, asthma, or emphysema"}

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T12:08:28.050005 · Updated: 2026-03-14T23:13:51.825108