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  5. Label Information: Sof Skin Vaporizing Chest Rub And Cough Suppressant

FDA Label for Sof Skin Vaporizing Chest Rub And Cough Suppressant

View Indications, Usage & Precautions

Table of Contents

    1. OTC - ACTIVE INGREDIENT
    2. OTC - PURPOSE
    3. INDICATIONS & USAGE
    4. WARNINGS
    5. OTC - PREGNANCY OR BREAST FEEDING
    6. OTC - DO NOT USE
    7. OTC - KEEP OUT OF REACH OF CHILDREN
    8. OTC - ASK DOCTOR
    9. DOSAGE & ADMINISTRATION
    10. INACTIVE INGREDIENT
    11. PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Sof Skin Vaporizing Chest Rub And Cough Suppressant Product Label

The following document was submitted to the FDA by the labeler of this product Viny Health And Beauty 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

Menthol 2.0%

Camphor 4.7%

Eucalyptus Oil 1.0%


Otc - Purpose



Purpose

Decongestant


Indications & Usage



USE:

To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.


Warnings



Warnings:

For external use only. Not for internal use. Avoid contact with eyes. Do not put in mouth, nostrils or on wounds or damaged skin.


Otc - Pregnancy Or Breast Feeding



If pregnant or breast feeding:

Consult a physician before use.


Otc - Do Not Use



Do not

use near open flame, in a microwave oven or in a container in which water is being heated except when adding to cold water in a hot steam vaporizer.


Otc - Keep Out Of Reach Of Children



Keep out of reach of children:

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


Otc - Ask Doctor



Consult a physician before use:

If you have asthma, emphysema, persistent or chronic cough, cough associated with smoking or excessive mucus. If muscle aches persist for more than 7 days or comes back or if cough lasts more than 7 days, comes back or occurs with fever, rash or a persistent headache.


Dosage & Administration



Directions:

Adults and children 2 years of age and older rub thick layer on chest and throat for temporary relief from nasal congestion and coughing due to colds or rub on sore, aching muscles. if desired, loosely cover with a soft dry cloth but keep clothing loose. Repeat up to three times daily, especially at bedtime. Children under 2 years of age, consult your physician.


Inactive Ingredient



Inactive Ingredients:

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


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