Viny - Sof Skin Vaporizing Chest Rub And Cough Suppressant (76436-127)

Viny - Sof Skin Vaporizing Chest Rub And Cough Suppressant (76436-127)
SPL v23
SPL
SPL Set ID 46ae16a4-b8a7-44de-ae1a-9bb503c15ea0
Route
TOPICAL
Published
Effective Date 2020-02-03
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (5.31 g) Menthol (2.26 g) Eucalyptus Oil (1.13 g)
Inactive Ingredients
Mineral Oil Nutmeg Oil Turpentine Thymol Cedar Leaf Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-18

Description

Active Ingredients Menthol 2.0% Camphor 4.7% Eucalyptus Oil 1.0%


Medication Information

Warnings and Precautions

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.

Indications and Usage

USE:

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

Dosage and 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.

Description

Active Ingredients Menthol 2.0% Camphor 4.7% Eucalyptus Oil 1.0%

Section 50565-1

Keep out of reach of children:

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

Section 50569-3

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.

Section 50570-1

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.

Section 51727-6

Inactive Ingredients:

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

Section 51945-4

Section 53414-9

If pregnant or breast feeding:

Consult a physician before use.

Section 55105-1

Purpose

Decongestant

Section 55106-9

Active Ingredients

Menthol 2.0%

Camphor 4.7%

Eucalyptus Oil 1.0%


Structured Label Content

Indications and Usage (34067-9)

USE:

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

Dosage and Administration (34068-7)

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.

Warnings and Precautions (34071-1)

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.

Section 50565-1 (50565-1)

Keep out of reach of children:

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

Section 50569-3 (50569-3)

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.

Section 50570-1 (50570-1)

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.

Section 51727-6 (51727-6)

Inactive Ingredients:

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

Section 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast feeding:

Consult a physician before use.

Section 55105-1 (55105-1)

Purpose

Decongestant

Section 55106-9 (55106-9)

Active Ingredients

Menthol 2.0%

Camphor 4.7%

Eucalyptus Oil 1.0%


Advanced Ingredient Data


Raw Label Data

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