1. Home
  2. Labeler Index
  3. Derma Wise Skin Care Ltd.
  4. 43347-172
  5. Label Information: Thera Wise Natural Vapor Rub

FDA Label for Thera Wise Natural Vapor Rub

View Indications, Usage & Precautions

Table of Contents

    1. OTHER
    2. ACTIVE INGREDIENT
    3. PURPOSE
    4. USES
    5. WARNINGS
    6. OTC - DO NOT USE
    7. OTC - STOP USE
    8. OTC - WHEN USING
    9. OTC - KEEP OUT OF REACH OF CHILDREN
    10. DIRECTIONS
    11. OTHER INFORMATION
    12. INACTIVE INGREDIENTS
    13. QUESTIONS OR COMMENTS?
    14. PRINCIPAL DISPLAY PANEL - 28 G TUBE BOX

Thera Wise Natural Vapor Rub Product Label

The following document was submitted to the FDA by the labeler of this product Derma Wise Skin Care Ltd.. 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.

Other



Drug Facts


Active Ingredient



Camphor Oil 4.8%


Purpose



Cough suppressant


Uses



  • Temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • Alleviates cough to help you get to sleep.

Warnings



For external use only

  • Do not take by mouth or place in nostrils.
  • Avoid contact with eyes, wounds or damaged skin.
  • Wash hands thoroughly after use.

    • Combustible: Keep away from fire or flames


Otc - Do Not Use



Do not use this product for persistent chronic cough such as occurs with smoking, asthma, or emphysema, or if cough is accompanied by excessive phlegm (mucus) unless directed by a doctor


Otc - Stop Use



Stop use and consult a doctor if cough:

  • persists for more than 1 week
  • tends to recur
  • is accompanied by fever, rash or persistant headache

    • A persistent cough may be a sign of a serious condition.


Otc - When Using



When using this product do not

  • heat
  • microwave
  • use near open flame
  • add to hot water or container where heating water

    • May cause splattering and result in burns.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children.


Directions



See warnings under "When using this product".

  • For use in adults and children 2 years and older.
  • Rub on the throat and chest as a thick layer
  • Cover with a warm dry cloth if desired.
  • Clothing should be left loose about the throat and chest to help vapours reach the nose and mouth.
  • Use up to three times daily or as directed by your doctor.
  • For use in children under 2 years of age: please consult a doctor or attending physician

Other Information



  • Store between 2° and 25° C (35° - 77° F)
  • Do not use if seal is broken

Inactive Ingredients



Argan Kernel Oil, Bitter Orange Oil, Castor Seed Oil, Eucalyptus Leaf Oil

Certified Organic

, Hydrogenated Olive Oil, Olive Fruit Oil, Olive Oil Unsaponifiables, Olive Squalane, , Peppermint Leaf Oil, Pine Needle Oil, Rhus Verniciflua Peel Wax, Rose Hip Seed Oil, Sunflower Seed Oil, Thyme Oil.


Questions Or Comments?



Call weekdays 9am to 5pm PST @ 1.888.488.1808


Principal Display Panel - 28 G Tube Box



THÉRA WISE®

Natural Vapor Rub
4.8 % CAMPHOR OIL, OINTMENT

Temporarily relieves cough due to minor throat
and bronchial irritation associated with a cold

WITH EUCALYPTUS LEAF, CAMPHOR BARK,
PINE NEEDLE AND THYME LEAF OIL,
ROSE HIP SEED & ARGAN OIL

NET WT 1OZ (28g)

PRINCIPAL DISPLAY PANEL - 28 g Tube Box - thera 01

PRINCIPAL DISPLAY PANEL - 28 g Tube Box - thera 01


* Please review the disclaimer below.