Viny (as Pld) - Sof Skin Vaporizing Chest Rub And Cough Suppressant (76436-144) - May 2025 New Formula

Viny (as Pld) - Sof Skin Vaporizing Chest Rub And Cough Suppressant (76436-144) - May 2025 New Formula
SPL v1
SPL
SPL Set ID 34626cf5-64fc-15c0-e063-6294a90aa310
Route
TOPICAL
Published
Effective Date 2025-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (natural) (4.8 g) Menthol (2.6 g) Eucalyptus Oil (1.2 g)
Inactive Ingredients
Paraffin Nutmeg Oil Turpentine Thymol Cedar Leaf Oil Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-02-04

Description

Camphor 4.8% Eucalyptus Oil 1.2% Menthol 2.6%

Purpose

Decongestant


Medication Information

Purpose

Decongestant

Description

Camphor 4.8% Eucalyptus Oil 1.2% Menthol 2.6%

Use:

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

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 51945-4

Section 53414-9

If pregnant or breast feeding:

Consult a physician before use.

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.

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.

Active Ingredients

Camphor 4.8%

Eucalyptus Oil 1.2%

Menthol 2.6%

Inactive Ingredients:

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


Structured Label Content

Use: (USE:)

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

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 51945-4 (51945-4)

Section 53414-9 (53414-9)

If pregnant or breast feeding:

Consult a physician before use.

Purpose

Decongestant

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.

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.

Active Ingredients

Camphor 4.8%

Eucalyptus Oil 1.2%

Menthol 2.6%

Inactive Ingredients:

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


Advanced Ingredient Data


Raw Label Data

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