Assured Vaporizing Chest Rub

Assured Vaporizing Chest Rub
SPL v1
SPL
SPL Set ID 272f32c5-ebd9-4995-98d0-2498743aa1c3
Route
TOPICAL
Published
Effective Date 2011-07-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Camphor (synthetic) (4.8 g) Menthol (2.6 g) Eucalyptus Oil (1.2 g)
Inactive Ingredients
Cedar Leaf Oil Nutmeg Oil Petrolatum Thymol Turpentine

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-07-06

Description

Camphor 4.8% Eucalyptus Oil 1.2% Menthol 2.6%

Purpose

Cough Suppressant and Topical analgesic Cough Suppressant Cough Suppressant and Topical Analgesic.


Medication Information

Purpose

Cough Suppressant and Topical analgesic

Cough Suppressant

Cough Suppressant and Topical Analgesic.

Description

Camphor 4.8% Eucalyptus Oil 1.2% Menthol 2.6%

Uses

on chest and throat, temporarily relieves cough due to common cold

on muscles and joints, temporarily relieves minor aches and pains.

Section 50569-3

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.

Section 51727-6

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).

Section 51945-4

Vaporizing Chest Rub

Cough Suppressant

Topical Analgesic

Ointment

NET WT 4OZ (113g)



DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

CHESAPEAKE, VA 23320

MADE IN CHINA

Warnings

For external use only; avoid contact with eyes.

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.

Do Not Use

by mouth

in nostrils

on wounds or damaged skin

with tight bandages

Active Ingredient

Camphor 4.8%

Eucalyptus Oil 1.2%

Menthol 2.6%



Other Information

store at room temperature

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.

When Using This Product, Do Not

heat, microwave, add hot water or any container where heating water may cause splattering and result in burns.


Structured Label Content

Uses

on chest and throat, temporarily relieves cough due to common cold

on muscles and joints, temporarily relieves minor aches and pains.

Section 50569-3 (50569-3)

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.

Section 51727-6 (51727-6)

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).

Section 51945-4 (51945-4)

Vaporizing Chest Rub

Cough Suppressant

Topical Analgesic

Ointment

NET WT 4OZ (113g)



DISTRIBUTED BY

GREENBRIER INTERNATIONAL, INC.

CHESAPEAKE, VA 23320

MADE IN CHINA

Purpose

Cough Suppressant and Topical analgesic

Cough Suppressant

Cough Suppressant and Topical Analgesic.

Warnings

For external use only; avoid contact with eyes.

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.

Do Not Use (Do not use)

by mouth

in nostrils

on wounds or damaged skin

with tight bandages

Active Ingredient

Camphor 4.8%

Eucalyptus Oil 1.2%

Menthol 2.6%



Other Information (Other information)

store at room temperature

Stop Use and Ask A Doctor If (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, (If pregnant or breast-feeding,)

ask a health professional before use

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.

When Using This Product, Do Not (When using this product, do not)

heat, microwave, add hot water or any container where heating water may cause splattering and result in burns.


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