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Name:Vaporizing Chest Rub
Manufacturer:Singhfam Corporation
Category:Over-the-counter (OTC) Marketed Drugs


Vaporizing Chest Rub

VAPORIZING CHEST RUB - camphor (synthetic), menthol and eucalyptus oil gel 
Singhfam 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

Drug Facts

Active Ingredients

Menthol 2.0%

Camphor 4.7%

Eucalyptus Oil 1.0%

Purpose

Decongestant

USES:

  • On chest and throat for temporary relief of nasal congestion and cough due to common cold.
  • On muscles and joints for temporary relief of minor aches and pains.

Warnings:

For external use only

Avoid contact with eyes

Keep out of reach of children

if swallowed, seek medical attention or contact a poison control center immediately.

If pregnant or breast-feeding, consult your doctor before use.

Do not use

near mouth, in nose, with tight bandages, on wounds or damaged skin.

Consult a doctor before use

if you have a cough with too much phlegm/mucus; persistent or chronic cough associated with asthma, emphysema or smoking.

when using this product,

do not heat, microwave, add to hot water or any container in which water is heating as splattering may occur resulting in burns.

Discontinue use and consult a doctor

if you experience:

  • recurring or persistent cough that lasts for more than 7 days or occurs with fever, rash or headache.
  • recurring or persistent muscle or joint aches and pains.

These symptoms may be a sign of a serious condition.

Directions:

  • For adults and children 2 years of age and over.
  • Apply a thick layer on throat and chest or rub on sore muscles and joints.
  • Cover loosely with a warm dry cloth if desired.
  • Keep clothing loose around throat and chest to allow vapors to reach the nose and mouth.
  • Apply no more than 3 times in a 24 hour period or as directed by doctor.

Other information:

Store at room temperature away from heat or flame.

Inactive Ingredients:

Petrolatum, Mineral Oil, Nutmeg Oil, Turpentine Oil, Thymol, Cedar Leaf Oil.

PRINCIPAL DISPLAY PANEL

elizabeth style
Vaporizing Chest Rub
Nasal Decongestant and Cough Suppressant

NET WT 4 OZ (113 G)

PRINCIPAL DISPLAY PANEL
Vaporizing Chest Rub
Net Wt 4 oz (113 g)

VAPORIZING CHEST RUB 
menthol and camphor and eucalyptus oil gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52920-124
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 4.7 g  in 113 g
MENTHOL (MENTHOL) MENTHOL 1.1 g  in 113 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL 1.1 g  in 110 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
MINERAL OIL  
NUTMEG OIL  
TURPENTINE  
THYMOL  
CEDAR LEAF OIL  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:52920-124-04 110 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 - Singhfam Corporation (019499958)
Establishment
Name Address ID/FEI Operations
Kim Chemicals LTD 650470164 MANUFACTURE

Revised: 10/2010 Singhfam Corporation



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


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