Vaporizing Rub

Vaporizing Rub
SPL v4
SPL
SPL Set ID 4c6a7ac0-be76-42b0-9a08-b287e70a3460
Route
TOPICAL
Published
Effective Date 2023-07-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (2.4 g) Menthol (1.3 g) Eucalyptus Oil (0.6 g)
Inactive Ingredients
Cedar Leaf Oil Nutmeg Oil Petrolatum Thymol Turpentine Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-07-18

Description

Drug Facts Active ingredient                                                                                              Purpose Camphor (synthetic) 4.8% ....................................................................Cough suppressant & topical analgesic Eucalyptus Oil 1.2% .............................................................................Cough suppressant Menthol 2.6% .......................................................................................Cough suppressant & topical analgesic


Medication Information

Warnings and Precautions

Warnings

For external use only; avoid contact with eyes.

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with tight bandages
Indications and Usage

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
Dosage and Administration

Directions:

  • see important warnings 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 or joints
  • 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 doctor
  • children under 2 years: do not use
  • cover with a warm, dry cloth if desired

Other information

  • store at room temperature
Description

Drug Facts Active ingredient                                                                                              Purpose Camphor (synthetic) 4.8% ....................................................................Cough suppressant & topical analgesic Eucalyptus Oil 1.2% .............................................................................Cough suppressant Menthol 2.6% .......................................................................................Cough suppressant & topical analgesic

Section 50565-1

Keep out of reach of children

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

Section 50569-3

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as 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 result in burns. Stop use and ask a doctor if

  • muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days.
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,ask a healthcare professional before use.

Section 51727-6

Inactive Ingredients

cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

Section 51945-4

PRINCIPAL DISPLAY PANEL

Vaporizing Rub

Camphor, Eucalyptus Oil, Menthol

• Cough Suppressant

• Topical Analgesic

Ointment

NET WT 1.76 OZ (50g)

Section 55106-9

Drug Facts

Active ingredient                                                                                              Purpose

Camphor (synthetic) 4.8% ....................................................................Cough suppressant & topical analgesic

Eucalyptus Oil 1.2% .............................................................................Cough suppressant

Menthol 2.6% .......................................................................................Cough suppressant & topical analgesic


Structured Label Content

Indications and Usage (34067-9)

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
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 the throat and chest for cough, or rub on sore aching muscles or joints
  • 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 doctor
  • children under 2 years: do not use
  • cover with a warm, dry cloth if desired

Other information

  • store at room temperature
Warnings and Precautions (34071-1)

Warnings

For external use only; avoid contact with eyes.

Do not use

  • by mouth
  • in nostrils
  • on wounds or damaged skin
  • with tight bandages
Section 50565-1 (50565-1)

Keep out of reach of children

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

Section 50569-3 (50569-3)

Ask a doctor before use if you have

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as 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 result in burns. Stop use and ask a doctor if

  • muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days.
  • cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,ask a healthcare professional before use.

Section 51727-6 (51727-6)

Inactive Ingredients

cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

Section 51945-4 (51945-4)

PRINCIPAL DISPLAY PANEL

Vaporizing Rub

Camphor, Eucalyptus Oil, Menthol

• Cough Suppressant

• Topical Analgesic

Ointment

NET WT 1.76 OZ (50g)

Section 55106-9 (55106-9)

Drug Facts

Active ingredient                                                                                              Purpose

Camphor (synthetic) 4.8% ....................................................................Cough suppressant & topical analgesic

Eucalyptus Oil 1.2% .............................................................................Cough suppressant

Menthol 2.6% .......................................................................................Cough suppressant & topical analgesic


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