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Name:Vaporizing Chest Rub
Manufacturer:Quality Care Distributors Llc
Category:Over-the-counter (OTC) Marketed Drugs


Vaporizing Chest Rub

VAPORIZING CHEST RUB - camphor (synthetic), eucalyptus oil and menthol gel 
Quality Care Distributors LLC

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 

Camphor 4.7%

Menthol 1.0%

Eucalyptus Oil 1.0%

Purpose

Cough suppressant, nasal decongestant & topical analgesic

Use:

Temporarily relives symptoms associated with the common cold:

  • cough
  • nasal congestion
  • chest congestion

Temporarily relieves minor aches and pains of muscles.

Directions:

See important warning under

“Do not use this product”

  • Children under 2 years of age, ask a doctor. 
  • Adults and children 2 years of age or older: Rub a thick layer on chest and throat. If desired, loosely cover with a soft dry cloth but keep clothing loose.
  • Repeat up to 3 times daily, or as directed by a doctor.

Warnings:

For external use only: Avoid contact with eyes

Ask a doctor before use if you have:  

Chronic cough that lasts or as occurs with smoking, asthma or emphysema. Cough with excessive phlegm (mucus).

Do not use this product;

Near an open flame. By adding water. By mouth. In a microwave oven. On wounds or damaged skin. With tight bandages. In nostrils. Added to hot water or any container where you are heating water. May cause splattering and result in burns.

Stop use and ask a doctor if:

Muscles aches and pains persist for more than 7 days or come back. Cough lasts more that 7 days comes back, or occurs with fever, rash, or headache that lasts. These could be signs of a serious condition. If pregnant or breast-feeding, consult a physician before use

Keep out of reach of children.

If swallowed, get medical helps or contact a Poison Control Center immediately

Inactive Ingredients:

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

Principal Display Panel

NEW!
FamilyCare
Chest Rub
VAPORIZING ACTION
Nasal Decongestant
Cough Suppressant
NET WT. 4 OZ
(113g)

Principal Display Panel
FamilyCare Chest Rub


VAPORIZING CHEST RUB 
menthol and camphor and eucalyptus oil gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:52271-158
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC) 5.31 g  in 113 g
EUCALYPTUS OIL (EUCALYPTUS OIL) EUCALYPTUS OIL 1.13 g  in 113 g
MENTHOL (MENTHOL) MENTHOL 1.13 g  in 113 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
PARAFFIN  
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:52271-158-01 113 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part341 09/21/2009

Labeler - Quality Care Distributors LLC (961937112)
Establishment
Name Address ID/FEI Operations
Anicare Pharmaceuticals Pvt. Ltd. 916837425 MANUFACTURE

Revised: 07/2010 Quality Care Distributors LLC



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


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