SPL v3
SPL
SPL Set ID acab200e-48bd-69e1-e053-2995a90afde0
Route
TOPICAL
Published
Effective Date 2020-08-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2013-10-01

Description

Active Ingredients Camphor 4.7% Menthol 1.25% Eucalyptus Oil 1.2%


Medication Information

Warnings and Precautions

Warnings

For external use only. Avoid contact with eyes.

Do not take by mouth or place in nostrils.

Indications and Usage

Uses

  • On chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation.
  • For the temporary relief of pain associated with minor skin irritation.

Dosage and Administration

Directions: see important warnings under “When using this product”

adults and children 2 years and over:

  • rub a thick layer on chest and throat
  • keep clothing loose around chest/throat to help vapors reach the nose/mouth
  • use up to 3 times daily as directed by doctor

children under 2 years of age: ask a doctor

Description

Active Ingredients Camphor 4.7% Menthol 1.25% Eucalyptus Oil 1.2%

Section 42229-5

PRINCIPAL DISPLAY PANEL

HEALTH SMART VAPORISING CHEST RUB GEL

DECONGESTANT AND COUGH SUPPRESSANT

NET WT.4 OZ (113g)

Section 50565-1

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

Section 50566-9

Stop use and ask a doctor if:

  • cough  that lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
Section 50567-7

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water. May cause splattering and result in burns
Section 50569-3

Ask doctor if you have,

  • cough that occurs with too much phlegm (mucus)
Section 50570-1

Do not use

  • by mouth
  • in nostrils
  • with tight bandages
  • on wounds or damaged skin
  • with persistent or chronic cough such as occurs with asthma, emphysema or smoking

Section 51727-6

Inactive Ingredients

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

Section 55105-1

Purpose

Cough Suppressant

Topical Analgesic

Nasal Decongestant

Section 55106-9

Active Ingredients

Camphor 4.7%

Menthol 1.25%

Eucalyptus Oil 1.2%

Chest Rub


Structured Label Content

Indications and Usage (34067-9)

Uses

  • On chest and throat, helps temporarily relieve cough as may occur with common cold and minor bronchial irritation.
  • For the temporary relief of pain associated with minor skin irritation.

Dosage and Administration (34068-7)

Directions: see important warnings under “When using this product”

adults and children 2 years and over:

  • rub a thick layer on chest and throat
  • keep clothing loose around chest/throat to help vapors reach the nose/mouth
  • use up to 3 times daily as directed by doctor

children under 2 years of age: ask a doctor

Warnings and Precautions (34071-1)

Warnings

For external use only. Avoid contact with eyes.

Do not take by mouth or place in nostrils.

Section 42229-5 (42229-5)

PRINCIPAL DISPLAY PANEL

HEALTH SMART VAPORISING CHEST RUB GEL

DECONGESTANT AND COUGH SUPPRESSANT

NET WT.4 OZ (113g)

Section 50565-1 (50565-1)

Keep out of the reach of children

If ingested get medical help or contact a Poison control center immediately

Section 50566-9 (50566-9)

Stop use and ask a doctor if:

  • cough  that lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache. These could be signs of a serious conditions
Section 50567-7 (50567-7)

When using this product, do not

  • heat
  • microwave
  • add to hot water or any container where heating water. May cause splattering and result in burns
Section 50569-3 (50569-3)

Ask doctor if you have,

  • cough that occurs with too much phlegm (mucus)
Section 50570-1 (50570-1)

Do not use

  • by mouth
  • in nostrils
  • with tight bandages
  • on wounds or damaged skin
  • with persistent or chronic cough such as occurs with asthma, emphysema or smoking

Section 51727-6 (51727-6)

Inactive Ingredients

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

Section 55105-1 (55105-1)

Purpose

Cough Suppressant

Topical Analgesic

Nasal Decongestant

Section 55106-9 (55106-9)

Active Ingredients

Camphor 4.7%

Menthol 1.25%

Eucalyptus Oil 1.2%

Chest Rub (chest rub)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)