FDA.reportPublic FDA data

Boroleum

Manufacturer
Santus LLC
Effective date
2017-02-07
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-02 01:20:07

Label at a glance#

ProductBoroleum for Nasal Soreness
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, PETROLATUM
Label structure10 sections

Indications and uses

For the temporary relief of pain and itching associated with minor cuts, scrapes, insect bites, and minor skin irritations (e.g. chafed nose) Temporarily protects minor cuts and scrapes Helps prevent, relieve, and temporarily protect chafed, chapped, or cracked skin

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Storage and handling

Store at room temperature

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 1%

Menthol 0.54%

White Petrolatum 97.92%

Purpose

OTC - PURPOSE SECTION

External analgesic

External analgesic

Skin protectant

Uses

INDICATIONS & USAGE SECTION

  • For the temporary relief of pain and itching associated with minor cuts, scrapes, insect bites, and minor skin irritations (e.g. chafed nose)
  • Temporarily protects minor cuts and scrapes
  • Helps prevent, relieve, and temporarily protect chafed, chapped, or cracked skin

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, discontinue use of this product and consult a physician

Do not use on:

OTC - DO NOT USE SECTION

  • deep or puncture wounds
  • animal bites
  • serious burns

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 2 years of age and older: apply to affected area not more than 3 to 4 times daily. Children under 2 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at room temperature

Inactive ingredients

INACTIVE INGREDIENT SECTION

Eucalyptol, methyl salicylate

Package Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Boroleum labelBoroleum label

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET2
MENTHOLACTIVE INGREDIENTL7T10EIP3A2
PETROLATUMACTIVE INGREDIENT4T6H12BN9U2
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET2
MENTHOLACTIVE MOIETYL7T10EIP3A2
PETROLATUMACTIVE MOIETY4T6H12BN9U2
EUCALYPTOLINACTIVE INGREDIENTRV6J6604TK2
METHYL SALICYLATEINACTIVE INGREDIENTLAV5U5022Y2

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
12090-123512090-1235-1, 12090-1235-0

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Name, UNII, Kind table
NameUNIIKind
EUCALYPTOLRV6J6604TKIACT
METHYL SALICYLATELAV5U5022YIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
PETROLATUM4T6H12BN9UACTIB

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 · 15 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YLOZENGE / ORAL53 mgExact identifier — unii candidate
8 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKSOLUTION / DENTALNAExact identifier — unii candidate
7 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YGEL / TOPICAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YTABLET / ORAL10 mgExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER / TOPICALNAExact identifier — unii candidate
8 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YDOUCHE / VAGINAL0.05 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKCAPSULE / ORALNAExact identifier — unii candidate
7 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YCAPSULE / ORAL16 mgExact identifier — unii candidate
8 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKDROPS / OPHTHALMIC0.02 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPOWDER, DENTIFRICE / DENTALNAExact identifier — unii candidate
8 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKSOLUTION / NASAL0.2 mg/1mlExact identifier — unii candidate
7 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKDROPS / NASAL0.2 mg/1mlExact identifier — unii candidate
7 equally ranked IID candidates
METHYL SALICYLATEMETHYL SALICYLATELAV5U5022YPASTE, DENTIFRICE / DENTAL1.1 %w/wExact identifier — unii candidate
8 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKPASTE, DENTIFRICE / DENTAL2.4 %w/wExact identifier — unii candidate
7 equally ranked IID candidates
EUCALYPTOLEUCALYPTOLRV6J6604TKJELLY / NASAL68.5 mgExact identifier — unii candidate
7 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
47f174e6-641e-5105-e054-00144ff88e8800bd405f-c1c2-402d-bc2e-fa25c8ffaa252017-02-07WarningsExact identifier
spl id: 47f174e6-641e-5105-e054-00144ff88e88
spl set id: 00bd405f-c1c2-402d-bc2e-fa25c8ffaa25

Reported adverse events (FAERS/openFDA)#

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