FDA Label for Assured Vaporizing Chest Rub

View Indications, Usage & Precautions

Assured Vaporizing Chest Rub Product Label

The following document was submitted to the FDA by the labeler of this product Greenbrier International, 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             1.25%

Eucalyptus Oil     1.2%


Otc - Purpose



Purpose

Cough suppressant/topical analgesic

Cough suppressant/topical analgesic

Cough suppressant


Indications & Usage



Uses

Temporarily relieves throat and chest

  • cough
  • nasal congestion due to common cold
  • aching muscles
  • minor aches and pains

Warnings



Warnings

For external use only. Avoid contact with eyes.


Otc - Do Not Use



Do not use

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

Otc - Ask Doctor



Ask a doctor before use if you have

  • asthama
  • excessive phlegm (mucus)
  • emphysema
  • persistent or chronic cough
  • cough associated with smoking

Otc - When Using



When using this product do not

  • heat
  • microwave
  • use near open flame
  • 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

  • muscle aches/pain persist 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.

Otc - Pregnancy Or Breast Feeding



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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children. In case of accidental ingestion, get medical help or contact a Poison Control Centre right away.


Dosage & Administration



Directions

  • see important warnings under "When using this product"
  • children under 2 years of age, ask a doctor before using this product
  • adults and children 2 years and older, rub a thick layer on chest and throat or rub on sore aching muscles. If desired, cover with a dry soft cloth but keep clothing loose. Repeat up to 3 times daily.

Other



Other information

  • Store at room temperature

Inactive Ingredient



Inactive ingredients

cedar leaf oil, nutmeg oil, paraffin, petrolatum, thymol, turpentine oil


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

ASSURED VAPORIZING CHEST RUB


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