Broncolin

Dosage form: ointment
Ingredients: CAMPHOR (NATURAL) 5.3g in 100g, MENTHOL 2.8g in 100g
Labeler: Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.
NDC Code: 66513-222

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.

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

BRONCOLIN 
camphor menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:66513-222
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (CAMPHOR (NATURAL)) CAMPHOR (NATURAL)5.3 g  in 100 g
MENTHOL (MENTHOL) MENTHOL2.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM 
PARAFFIN 
Packaging
#Item CodePackage Description
1NDC:66513-222-0140 g in 1 JAR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/2011
Labeler - Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. (814400404)
Establishment
NameAddressID/FEIOperations
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.814400404manufacture

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

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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