Vaporx Balm
FDA Label NDC 54162-450

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Geritrex Llc for the product Vaporx Balm (NDC 54162-450). 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:, uses:, warnings:, ask your doctor before use if you have:, when using this product, do not:, stop use and ask doctor if:, directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients:

Camphor 4.8%
Eucalyptus Oil 1.2%
Menthol 2.6%

Purpose:

Camphor - Cough Suppressant and Topical Analgesic
Eucalyptus Oil- Cough Suppressant
Menthol- Cough Suppressant and Topical Analgesic 

Uses:

- On chest and throat, temporarily relieves cough due to common cold

- On muscles and joints, temporarily relieves minor aches and pains

Warnings:

For external use only; avoid contact with eyes

Ask Your Doctor Before Use If You Have:

- Persistent or chronic cough such as occurs with smoking, asthma or emphysema. - If excessive mucous present

When Using This Product, Do Not:

- heat - microwave - add to hot water or any container with heating water.
May cause splattering and result in burns 

Stop Use And Ask Doctor If:

- muscle aches and pains persists more than 7 days
- cough lasts more than 7 days, comes back, or occurs with fever, rash, or persistent headache.
These could be signs of a serious condition

Directions:

- Adults and children 2 years and over
- Rub a thick layer on chest & throat or rub on sore aching muscles
- Cover with warm, dry cloth if desired.
- Keep clothing loose around throat/chest to help vapors reach the nose and mouth
- repeat up to three times per 24 hours or as directed by doctor 

Inactive Ingredients:

nutmeg oil, modified petrolatum, thymol, turpentine oil

* Please review the disclaimer below.