Thera Wise Natural Vapor Rub
FDA Label NDC 43347-172

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Derma Wise Skin Care Ltd. for the product Thera Wise Natural Vapor Rub (NDC 43347-172). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - stop use, otc - when using, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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?

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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)

Principal Display Panel (28 g Tube Box)

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