Active Ingredients
Camphor 4.8%
Eucalyptus Oil 1.2%
Menthol 2.6%
Sofskin Vaporizing Chest Rub And Cough Suppressant Ointment
FDA Label NDC 76436-144
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Viny Health And Beauty Inc for the product Sofskin Vaporizing Chest Rub And Cough Suppressant (NDC 76436-144). 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 active ingredients, purpose, use:, warnings:, otc - pregnancy or breast feeding, otc - do not use, otc - keep out of reach of children, otc - ask doctor, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Decongestant
Use:
To temporarily relieve nasal congestion, chest congestion and cough due to the common cold. Temporarily relieves minor aches and pains.
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.
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 Ingredients:
Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil
Package Label.Principal Display Panel
Label (Vaporub 12thmay)
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