Broncolin

Manufacturer
Distribuidora de Alimentos Naturales y Nutricionales, S.A. de C.V.
Effective date
2019-11-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:01:23

Label at a glance#

ProductBroncolin
Active ingredientCAMPHOR (NATURAL), MENTHOL
Label structure9 sections

Indications and uses

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

Dosage and administration

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 5.3%
Menthol 2.8%

Purpose

OTC - PURPOSE SECTION

Antitussive
Antitussive

Uses

INDICATIONS & USAGE SECTION

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

Warning

WARNINGS SECTION

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

OTC - ASK DOCTOR SECTION

• cough persists for more than 1 week
• ​tends to recur

• is accompanied by fever, rash, or persistent headache.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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

INACTIVE INGREDIENT SECTION

petrolatum, paraffin

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Package LabelPackage Label

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
66513-222-012019-11-14C16284748780-1960f7f55-d08e-8e05-e053-dbdaa90a074aDRUG FACTS
66513-222-012019-10-29C16284748780-1960f7f55-d08e-8e05-e053-dbdaa90a074aDRUG FACTS

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (NATURAL)ACTIVE INGREDIENTN20HL7Q9411
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
CAMPHOR (NATURAL)ACTIVE MOIETYN20HL7Q9411
MENTHOLACTIVE MOIETYL7T10EIP3A1
PARAFFININACTIVE INGREDIENTI9O0E3H2ZE1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 6 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
66513-22266513-222-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 29 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PARAFFINPARAFFINI9O0E3H2ZEAEROSOL, FOAM / TOPICAL14235 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET, EXTENDED RELEASE / ORAL0.18 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USPONGE / TOPICALNAExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / RECTAL38 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, DELAYED RELEASE / ORAL0.2 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UEMULSION / TOPICAL7.8 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UTABLET / ORAL3.5 mgExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, COATED / ORAL0.07 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZEOINTMENT / TOPICAL2860 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET, EXTENDED RELEASE / ORAL321 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESUSPENSION / TOPICAL11726 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / VAGINAL4084 mgExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECREAM / TOPICAL300 mgExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZESOAP / TOPICAL0.4 %w/wExact identifier — unii candidate
11 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / OPHTHALMIC88.4 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZETABLET / ORAL0.7 mgExact identifier — unii candidate
11 equally ranked IID candidates
PARAFFINPARAFFINI9O0E3H2ZECAPSULE, EXTENDED RELEASE / ORAL100 mgExact identifier — unii candidate
11 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
9756ba2b-8bad-09be-e053-2a95a90a0405a0b028bd-8c1d-420b-b14d-63cc107ddb822019-11-14WarningsExact identifier
spl id: 9756ba2b-8bad-09be-e053-2a95a90a0405
spl set id: a0b028bd-8c1d-420b-b14d-63cc107ddb82

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.