FDA Label for Vaporizing Chest Rub

View Indications, Usage & Precautions

Vaporizing Chest Rub Product Label

The following document was submitted to the FDA by the labeler of this product Four Seasons Trading Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

Otc - Active Ingredient



Active Ingredients

Camphor            4.7%

Menthol             1.0%

Eucalyptus Oil   1.0%


Otc - Purpose



Purpose

Cough Suppressant

Topical Analgesic

Nasal Decongestant


Indications & 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.

Warnings



Warnings

For external use only. Avoid contact with eyes.

Do not take by mouth or place in nostrils.


Otc - Do Not Use



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


Otc - Ask Doctor



Ask doctor if you have,

  • cough that occurs with too much phlegm (mucus)

Otc - When Using



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

Otc - Stop Use



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

Otc - Keep Out Of Reach Of Children



Keep out of the reach of children

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


Dosage & 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


Inactive Ingredient



Inactive Ingredients

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


Other



PRINCIPAL DISPLAY PANEL

VAPORIZING CHEST RUB GEL

DECONGESTANT AND COUGH SUPPRESSANT

NET WT. 4 OZ (113g)


Package Label.Principal Display Panel




* Please review the disclaimer below.