Drug Facts
Camphor 6.2%
Vaporizing Steam Liquid Solution
FDA Label NDC 13709-332
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Neilmed Pharmaceuticals Inc. for the product Vaporizing Steam Liquid (NDC 13709-332). 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 drug facts, purpose, warnings, ask a doctor before use if, when using this product, do not, stop use and ask a doctor if, keep out of reach of children, directions, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Camphor 6.2%......................Cough Suppressant
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
- cough that occurs with too much phlegm (mucus)
When Using This Product, Do Not
- Heat
- Microwave
- use near an open flame
- take by mouth
- direct stream from the vaporizer too close to the face
- add to hot water or any container in which you are heating water except when adding to cold water in a hot steam vaporizer. Improper use may cause the mixture to splatter and cause burns.
Stop Use And Ask A Doctor If
cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache. These could be signs of a serious condition.
Keep Out Of Reach Of Children
In case of eye exposure flush eyes with water. In case of accidental ingestion, seek medical help or contact a Poison Control Center right away. (1-800-222-1222)
Directions
- See important warnings under "When using this product"
- Adults & Children 2 years & over: use 1 tablespoon of solution for each quart of water, or 1-1/2 teaspoons of solution for 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 medicated vapors
- may be repeated up to 3 times a day
- Children under 2 years: do not use
- use 1 tablespoon of solution for each quart of water or 1-1/2 teaspoons of solution for 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 medicated vapors
- may be repeated up to 3 times a day
Adults & Children 2 years & over:
Children under 2 years: do not use
Other Information
- Close container tightly and store at room temperature away from heat
Important:
Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product
Inactive Ingredients
dimethicone, eucalyptus(eucalyptus oil) leaf oil, laureth-7, menthol, myristica fragrans(nutmeg) kernel oil, poloxamer 124, SD alcohol 40-8, thuja occidentalis (cedar leaf) oil
Uses
Uses temporarily relieves cough due to minor throat and bronchial irritation associated with a cold.
* Please review the disclaimer below.
