Vaporizing Rub Ointment
FDA Label NDC 73492-716

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Alaina Healthcare Private Limited for the product Vaporizing Rub (NDC 73492-716). 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 otc - active ingredient, indications & usage, warnings, otc - ask doctor, otc - keep out of reach of children, dosage & administration, inactive ingredient, package label.principal display panel, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

→ Otc - Active Ingredient

→ Indications & Usage

→ Warnings

→ Otc - Ask Doctor

→ Otc - Keep Out Of Reach Of Children

→ Dosage & Administration

→ Inactive Ingredient

→ Package Label.principal Display Panel

Otc - Active Ingredient

Drug Facts

Active ingredient Purpose

Camphor (synthetic) 4.8% ....................................................................Cough suppressant & topical analgesic

Eucalyptus Oil 1.2% .............................................................................Cough suppressant

Menthol 2.6% .......................................................................................Cough suppressant & topical analgesic

Indications & Usage

Uses:

temporarily relieves cough due to minor throat and bronchial irritation associated with a cold
temporarily relieves minor aches and pains of muscles and joints

Warnings

For external use only; avoid contact with eyes.

Do not use

by mouth
in nostrils
on wounds or damaged skin
with tight bandages

Otc - Ask Doctor

Ask a doctor before use if you have

cough that occurs with too much phlegm (mucus)
persistent or chronic cough such as occurs with smoking, asthma or emphysema

When using this product, do not

heat
microwave
add to hot water or any container where heating water.

May cause splattering and result in burns. Stop use and ask a doctor if

muscle aches and pains worsen or persist for more than 7 days or clear up and occur again within a few days.
cough persists for more than 1 week, tends to recur, or is accompanied by fever, rash, or persistent headache. A persistent cough may be a sign of a serious condition.

If pregnant or breast-feeding,ask a healthcare professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children

If swallowed, get medical help or contact a Poison Control Center right away.

Dosage & Administration

Directions:

see important warnings under "When using this product"
adults and children 2 years and over:
rub a thick layer on the throat and chest for cough, or rub on sore aching muscles or joints
clothing should be left loose about the throat and chest to help vapors reach the nose and mouth
use up to 3 times daily or as directed by doctor
children under 2 years: do not use
cover with a warm, dry cloth if desired

Other information