Vaporex ®

Vaporex ®
SPL v4
SPL
SPL Set ID 971943b1-4199-4f75-9d2d-61242d346b5f
Route
TOPICAL
Published
Effective Date 2017-11-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2013-03-12 Until 2017-11-07

Description

Drug Facts


Medication Information

Description

Drug Facts

Uses
  • on chest and throat, for the temporary relief of cough due to the common cold
  • on muscles and joints, for the temporary relief of minor aches and pains
Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Section 53414-9

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

Section 55105-1
Active Ingredients Purposes
Camphor 4.8% Cough suppressant & topical analgesic
Eucalyptus Oil 1.2% Cough suppressant
Menthol 2.6% Cough suppressant & topical analgesic
Warnings

For external use only; avoid contact with eyes.

Directions

See important warnings under "When using this product."

  • adults and children 2 years and over:

    For cough suppression
    • rub a thick layer on throat and chest
    • cover with a warm, dry cloth if desired
    • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • use up to three times daily or as directed by a doctor.

    For minor aches and pains of muscles and joints
    • apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use

Do Not Use
  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin
Other Information
  • store at room temperature
Inactive Ingredients

cedarleaf oil, nutmeg oil, paraffin wax, petrolatum, thymol, turpentine oil

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 lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
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.
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
Principal Display Panel 56.7 G Jar Carton

FOR ADULTS & CHILDREN

MEDICATED CHEST RUB

Triple Action Relief

VAPOREX ®

• OINTMENT •

NO ARTIFICIAL COLORS

OR FRAGRANCES

COUGH SUPPRESSANT

TOPICAL ANALGESIC

NET WT 2.0 OZ (56.7 g)


Structured Label Content

Uses
  • on chest and throat, for the temporary relief of cough due to the common cold
  • on muscles and joints, for the temporary relief of minor aches and pains
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center immediately.

Section 53414-9 (53414-9)

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

Section 55105-1 (55105-1)
Active Ingredients Purposes
Camphor 4.8% Cough suppressant & topical analgesic
Eucalyptus Oil 1.2% Cough suppressant
Menthol 2.6% Cough suppressant & topical analgesic
Warnings

For external use only; avoid contact with eyes.

Directions

See important warnings under "When using this product."

  • adults and children 2 years and over:

    For cough suppression
    • rub a thick layer on throat and chest
    • cover with a warm, dry cloth if desired
    • clothing should be loose about throat and chest to help vapors reach the nose and mouth
  • use up to three times daily or as directed by a doctor.

    For minor aches and pains of muscles and joints
    • apply to affected area not more than 3 to 4 times daily

Children under 2 years: do not use

Do Not Use (Do not use)
  • by mouth
  • with tight bandages
  • in nostrils
  • on wounds or damaged skin
Other Information (Other information)
  • store at room temperature
Inactive Ingredients (Inactive ingredients)

cedarleaf oil, nutmeg oil, paraffin wax, petrolatum, thymol, turpentine oil

Stop Use and Ask A Doctor If (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 lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.
When Using This Product, Do Not (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.
Ask A Doctor Before Use If You Have (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
Principal Display Panel 56.7 G Jar Carton (PRINCIPAL DISPLAY PANEL - 56.7 g Jar Carton)

FOR ADULTS & CHILDREN

MEDICATED CHEST RUB

Triple Action Relief

VAPOREX ®

• OINTMENT •

NO ARTIFICIAL COLORS

OR FRAGRANCES

COUGH SUPPRESSANT

TOPICAL ANALGESIC

NET WT 2.0 OZ (56.7 g)


Advanced Ingredient Data


Raw Label Data

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