You are here: Home > Over-the-counter (OTC) Drugs > B > Broncolin (Distribuidora De Alimentos Naturales Y Nutricionales, S.a. De C.v.)

Name:Broncolin
Manufacturer:Distribuidora De Alimentos Naturales Y Nutricionales, S.a. De C.v.
Category:Over-the-counter (OTC) Marketed Drugs


DRUG FACTS

BRONCOLIN  - camphor (natural) and menthol ointment 
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.

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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DRUG FACTS

Active Ingredients
Camphor 5.3%
Menthol 2.8%


Purpose
Antitussive
Antitussive

Uses
Temporarily reduces cough due to minor bronchial irritation associated with the common cold.

Warning
A persistent cough maybe a sign of a serious condition. For External Use Only. Do not take by mouth or place in nostrils.

Consult a doctor if
  • cough persists for more than 1 week
  • tends to recur
  • is accompanied by fever, rash, or persistent headache.

Keep out of reach of children. If case of accidental ingestion, get medical help or contact a Poison Control Center right away.

Directions
Adults and children 2 to under 12 years of age

  • Rub on throat and chest as a thick layer. The area of application may be covered with a warm, dry cloth if desired. Clothing should be left loose about the throat and chest to help the vapor rise to reach the nose and mouth.
  • Application may be repeated up to three times daily or as directed by a doctor
  • Consult a doctor for children under 2 years of age

Inactive Ingredients Petrolatum, paraffin

Package Label
image of package label


BRONCOLIN 
camphor menthol ointment
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:66513-222
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL) 5.3 g  in 100 g
MENTHOL (MENTHOL) MENTHOL 2.8 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
PETROLATUM  
PARAFFIN  
Product Characteristics
Color      Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:66513-222-01 40 g in 1 JAR None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph final part341 06/15/2011

Labeler - Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. (814400404)
Establishment
Name Address ID/FEI Operations
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. 814400404 manufacture

Revised: 05/2011 Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.



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


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