Vaporizing Chest Rub (Menthol Camphor Eucalyptus Oil) Gel [Nova Petroleum & Chemicals Corporation] -

VAPORIZING CHEST RUB (MENTHOL CAMPHOR EUCALYPTUS OIL) GEL [NOVA PETROLEUM & CHEMICALS CORPORATION]
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NDC	52069-101-04
Set ID	8f5dfbfe-142a-4e56-8136-75aec9aa5343
Category	HUMAN OTC DRUG LABEL
Packager	Nova Petroleum & Chemicals Corporation
Generic Name
Product Class
Product Number
Application Number	PART341

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SPL UNCLASSIFIED SECTION

Label for

NOVA PETROLEUM & CHEMICALS CORP.

Vaporizing Chest Rub

Drug Facts:
Active Ingredients:

Camphor 4.7%
Purpose:

Cough suppressant & topical analgesic
Active Ingredients:

Menthol1.0%
Purpose:

Cough suppressant & topical analgesic
Active Ingredients:

Eucalyptus Oil 1.0%
Purpose:

Cough suppressant
Use:

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, with tight bandages, in nostrils or on wounds or damaged skin.
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 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 older:

Rub a thick layer on chest & 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 24 hours or as directed by doctor.

Children under 2 years of age: ask a doctor.
Other information:

Store at room temperature.

Made in India

Imported by:

      Nova Petroleum & Chemicals Corp.

      Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533

      www.novawax.com

Distributed by:

      Vini Health and Beauty Products Inc.

      3 Roethal Drive Suite 1 D

      Hopewell Junction, NY 12533
Principal Display Panel

Sofskin
Topical Analgesic
Cough Suppressant
Vaporizing
Chest Rub
NET WT 3.53 OZ (100 g)

INGREDIENTS AND APPEARANCE

VAPORIZING CHEST RUB
menthol camphor eucalyptus oil gel

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:52069-101
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR, (+/-)- (UNII: 5TJD82A1ET) (CAMPHOR, (+/-)- - UNII:5TJD82A1ET)	CAMPHOR, (+/-)-	4.7 g in 110 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	1.1 g in 110 g
EUCALYPTUS OIL (UNII: 2R04ONI662) (EUCALYPTUS OIL - UNII:2R04ONI662)	EUCALYPTUS OIL	1.1 g in 110 g

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:52069-101-04	110 g in 1 JAR

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC MONOGRAPH FINAL	part341	03/10/2010

Labeler - Nova Petroleum & Chemicals Corporation (831871731)

Name	Address	ID/FEI	Business Operations
Establishment
Kim Chemicals LTD		650470164	MANUFACTURE

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Medic

VAPORIZING CHEST RUB (MENTHOL CAMPHOR EUCALYPTUS OIL) GEL [NOVA PETROLEUM & CHEMICALS CORPORATION]

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