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

BRONCOLIN
camphor menthol ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:66513-222
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941)	CAMPHOR (NATURAL)	5.3 g in 100 g
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A)	MENTHOL	2.8 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
PETROLATUM (UNII: 4T6H12BN9U)
PARAFFIN (UNII: I9O0E3H2ZE)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:66513-222-01	40 g in 1 JAR; Type 0: Not a Combination Product	06/15/2011	12/02/2019

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part341	06/15/2011	12/02/2019

Labeler - Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V. (814400404)

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