Broncolin by Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. DRUG FACTS

Broncolin by

Drug Labeling and Warnings

Broncolin by is a Otc medication manufactured, distributed, or labeled by Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

BRONCOLIN- camphor 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

Package Label

BRONCOLIN 
camphor menthol ointment
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC: 66513-222
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5.3 g  in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL2.8 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
PETROLATUM (UNII: 4T6H12BN9U)  
PARAFFIN (UNII: I9O0E3H2ZE)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 66513-222-0140 g in 1 JAR; Type 0: Not a Combination Product06/15/201112/02/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart34106/15/201112/02/2019
Labeler - Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. (814400404)
Establishment
NameAddressID/FEIBusiness Operations
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.814400404manufacture(66513-222)

Revised: 11/2019
Document Id: 9756ba2b-8bad-09be-e053-2a95a90a0405
Set id: a0b028bd-8c1d-420b-b14d-63cc107ddb82
Version: 2
Effective Time: 20191114
 
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.