Active Ingredient
Camphor (Synthetic) 6.2%
Vapo Steam Liquid
FDA Label NDC 76162-030
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates, Llc for the product Vapo Steam (NDC 76162-030). 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 ingredient, purpose, uses, warnings, ask a doctor before use if you have, when using this product, do not, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Cough suppressant
Uses
temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.
Warnings
For external use only.
Flammable: Keep away from fire or flame. For steam inhalation only.
Ask A Doctor Before Use If You Have
- a persistent or chronic cough such as occurs with smoking, asthma or emphysema
- cough that occurs with too much phlegm (mucus)
When Using This Product, Do Not
- heat
- microwave
- use near an open flame
- direct steam from the vaporizer too close to the face
- add to hot water or any container where heating water except when adding to cold water only in a hot steam vaporizer. May cause splattering and result in burns.
Stop Use And Ask A Doctor If
cough lasts more than 7 days, comes back, or occurs with fever, rash, or headache that lasts. These could be signs of serious condition.
Keep Out Of Reach Of Children.
In case of eye exposure (flush eyes with water); or in case of accidental igestion, seek medical help or contact a Poison Control Center right away.
Directions
- see important warnings under "When using this product"
- adults & children 2 years & over:
- children under 2 years: do not use
add 1 tablespoon of solution to each quart of water or 1½ teaspoons of solution to each pint of water
add solution directly to cold water only in a hot steam vaporizer
follow manufacturer's directions for using vaporizer
breathe in the medicated vapors
use up to three times daily or as directed by a doctor
Other Information
- close container tightly and store at room temperature away from heat
Inactive Ingredients
dimenthicone, eucalyptus globulus (eucalyptus oil) leaf oil, laureth-7, menthol, myristica fragrans (nutmeg) kernel oil, poloxamer 124, SD alcohol 40-B, thuja occidentalis (cedar leaf) oil
* Please review the disclaimer below.
