SPL v4
SPL
SPL Set ID c6ea663a-9c4f-4d1a-a937-002806a8530a
Route
TOPICAL
Published
Effective Date 2015-08-10
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4.8 g) Menthol (2.6 g) Eucalyptus Oil (1.2 g)
Inactive Ingredients
Petrolatum Nutmeg Oil Turpentine Oil Cedar Leaf Oil Thymol Paraffin

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-08-10
Description

Active Ingredients Camphor            4.8% Menthol              2.6% Eucalyptus Oil    1.2%

Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes.

Indications and Usage

Uses

Temporarily releives symptoms associated with the common cold:

  • cough
  • nasal congestion
  • chest congestion

Temporarily relives minor aches and pains of muscles.

Dosage and Administration

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 or older:

  • rub a thick layer on chest and throat
  • if desired, loosely cover with a soft dry cloth but keep clothing loose
  • repeat up to 3 times daily, or as directed by a doctor
Description

Active Ingredients Camphor            4.8% Menthol              2.6% Eucalyptus Oil    1.2%

Section 50565-1

Keep out of the reach of children

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

Section 50566-9

Stop use and ask a doctor if:

  • if muscle aches and pains persist for more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions
  • if pregnant or breast-feeding, consult a physician before use.
Section 50569-3

Ask a doctor before use if you have,

  • chronic cough that lasts or as occurs with smoking, asthma, or emphysema
  • cough with excessive phlegm (mucus)
Section 50570-1

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 results in burns
Section 51727-6

Inactive Ingredients

Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Parrafin.

Section 51945-4

PRINCIPAL DISPLAY PANEL

CHEST RUB VAPORIZING ACTION GEL

NASAL DECONGESTANT AND COUGH SUPPRESSANT

NET WT. 4 OZ (113g)

Section 55105-1

Purpose

Cough Suppressant

Nasal Decongestant

Topical Analgesic

Section 55106-9

Active Ingredients

Camphor            4.8%

Menthol              2.6%

Eucalyptus Oil    1.2%

Structured Label Content

Indications and Usage (34067-9)

Uses

Temporarily releives symptoms associated with the common cold:

  • cough
  • nasal congestion
  • chest congestion

Temporarily relives minor aches and pains of muscles.

Dosage and Administration (34068-7)

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 or older:

  • rub a thick layer on chest and throat
  • if desired, loosely cover with a soft dry cloth but keep clothing loose
  • repeat up to 3 times daily, or as directed by a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes.

Section 50565-1 (50565-1)

Keep out of the reach of children

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

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • if muscle aches and pains persist for more than 7 days or come back
  • cough lasts more than 7 days, comes back, or occurs with fever, rash or headache that lasts. These could be signs of a serious conditions
  • if pregnant or breast-feeding, consult a physician before use.
Section 50569-3 (50569-3)

Ask a doctor before use if you have,

  • chronic cough that lasts or as occurs with smoking, asthma, or emphysema
  • cough with excessive phlegm (mucus)
Section 50570-1 (50570-1)

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 results in burns
Section 51727-6 (51727-6)

Inactive Ingredients

Petrolatum, Nutmeg Oil, Turpentine Oil, Cedar Leaf Oil, Thymol, Parrafin.

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

CHEST RUB VAPORIZING ACTION GEL

NASAL DECONGESTANT AND COUGH SUPPRESSANT

NET WT. 4 OZ (113g)

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Nasal Decongestant

Topical Analgesic

Section 55106-9 (55106-9)

Active Ingredients

Camphor            4.8%

Menthol              2.6%

Eucalyptus Oil    1.2%

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:04:59.268015 · Updated: 2026-03-14T23:06:13.532900