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  5. Label Information: Vaporizing Rub

FDA Label for Vaporizing Rub

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. INDICATIONS & USAGE
    3. WARNINGS
    4. OTC - ASK DOCTOR
    5. OTC - KEEP OUT OF REACH OF CHILDREN
    6. DOSAGE & ADMINISTRATION
    7. INACTIVE INGREDIENT
    8. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Vaporizing Rub Product Label

The following document was submitted to the FDA by the labeler of this product Alaina Healthcare Private Limited. 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



Drug Facts

Active ingredient                                                                                              Purpose

Camphor (synthetic) 4.8% ....................................................................Cough suppressant & topical analgesic

Eucalyptus Oil 1.2% .............................................................................Cough suppressant

Menthol 2.6% .......................................................................................Cough suppressant & topical analgesic


Indications & Usage



Uses:

  • temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
  • temporarily relieves minor aches and pains of muscles and joints

Warnings



Warnings

For external use only; avoid contact with eyes.

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

  • cough that occurs with too much phlegm (mucus)
  • persistent or chronic cough such as occurs with smoking, asthma or emphysema

    • 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. 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 persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

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


Otc - Keep Out Of Reach Of Children



Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.


Dosage & Administration



Directions:

  • see important warnings under "When using this product"
  • adults and children 2 years and over:
  • rub a thick layer on the throat and chest for cough, or rub on sore aching muscles or joints
  • clothing should be left loose about the throat and chest to help vapors reach the nose and mouth
  • use up to 3 times daily or as directed by doctor
  • children under 2 years: do not use
  • cover with a warm, dry cloth if desired

    • Other information

    • store at room temperature

Inactive Ingredient



Inactive Ingredients

cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil


Package Label.Principal Display Panel



PRINCIPAL DISPLAY PANEL

Vaporizing Rub

Camphor, Eucalyptus Oil, Menthol

• Cough Suppressant

• Topical Analgesic

Ointment

NET WT 1.76 OZ (50g)

label - chest rub

label - chest rub


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