Assured Vaporizing Chest Rub
FDA Label NDC 33992-7995

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Greenbrier International, Inc. for the product Assured Vaporizing Chest Rub (NDC 33992-7995). 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, do not use, otc - ask doctor, when using this product, do not, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredient

Camphor 4.8%

Eucalyptus Oil 1.2%

Menthol 2.6%


Purpose

Cough Suppressant and Topical analgesic

Cough Suppressant

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.

Do Not Use

by mouth

in nostrils

on wounds or damaged skin

with tight bandages

Otc - Ask Doctor

Ask 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 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 persist more than 7 days or come back

cough lasts more than 7 days, comes back, or occurs with fever, rash or persistent headache.

These could be signs of a serious condition.

If Pregnant Or Breast-Feeding,

ask a health professional before use

Keep Out Of Reach Of Children.

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

Directions

see important warnings under "When using this product"

adults and children 2 years and over:

rub a thick layer on chest and throat or rub on sore aching muscles

cover with a warm, dry cloth if desired

keep clothing loose about throat/chest to help vapors reach the nose/mouth

repeat up to three times per 24hours or as directed by doctor

children under 2 years do not use.

Other Information

store at room temperature

Inactive Ingredient

cedarleaf oil, nutmeg oil, petrolatum, thymol, turpentine oil

*This product is not manufactured or distributed by Procter and Gamble, distributor of the registered trademark Vicks(r).

Package Label.Principal Display Panel

Vaporizing Chest Rub

Cough Suppressant

Topical Analgesic

Ointment

NET WT 4OZ (113g)


DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

CHESAPEAKE, VA 23320

MADE IN CHINA

Vaporizing Chest Rub (Vcr)

Vaporizing Chest Rub (Vcr)

* Please review the disclaimer below.