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Name:Vaporizing Chest Rub
Manufacturer:Nova Petroleum & Chemicals Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Vaporizing Chest Rub

VAPORIZING CHEST RUB - camphor, (+/-)-, menthol and eucalyptus oil gel 
Nova Petroleum & Chemicals Corporation

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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Vaporizing Chest Rub

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)

Principal Display Panel
Sofskin Vaporizing Chest Rub
Net Wt 3.52 Oz (100 g)


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 DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR, (+/-)- (CAMPHOR, (+/-)-) CAMPHOR, (+/-)- 4.7 g  in 110 g
MENTHOL (MENTHOL) MENTHOL 1.1 g  in 110 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL 1.1 g  in 110 g
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52069-101-04 110 g in 1 JAR None

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

Labeler - Nova Petroleum & Chemicals Corporation (831871731)
Establishment
Name Address ID/FEI Operations
Kim Chemicals LTD 650470164 MANUFACTURE

Revised: 03/2010 Nova Petroleum & Chemicals Corporation



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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