FDA.reportPublic FDA data

Bumooly-S

Manufacturer
Scott Holdings Co., Ltd. | Hyundai Pharmaceutical Co., Ltd.
Effective date
2014-05-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:39:18

Label at a glance#

ProductBumooly-S
Active ingredientMETHYL SALICYLATE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

methyl salicylate


INACTIVE INGREDIENT SECTION

camphor, menthol, glycyrrhetic acid, diphenhydramine hcl, dibucaine hcl


OTC - PURPOSE SECTION

aczema, dermatitis, erosion, miliaria, pruritus, pernio, insect bite, hives


OTC - KEEP OUT OF REACH OF CHILDREN SECTION

keep out or reach of the children


INDICATIONS & USAGE SECTION

apply to the affected area once to several times a day


WARNINGS SECTION

avoid contact with eyes, if this product splashes in to your eyes, wash immediately with water


DOSAGE & ADMINISTRATION SECTION

for external use only


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

package label
package label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-138806420004015GTIN-13: 8806420004015
EAN-13: 8806420004015
GTIN storage (14 digits): 08806420004015		label.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0e2e0f88-b076-afe1-4bdd-32bca4375becProduct name320250127
3e48c9c4-918d-5d23-2f0b-d2398b06be54Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68994-2001-12019-11-27C16284748780-19855e2a2-3393-60a7-e053-dbdaa90a05bdDrug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68994-2001-1Bumooly-S50 mL in 1 BOTTLESOLUTION501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68994-2001BUMOOLY-S (METHYL SALICYLATE) SOLUTION [SCOTT HOLDINGS CO., LTD.]1Legacy NDC, 1 package rows20140516_bdc48a36-d6da-4ecf-a2a7-fe9ef9049f00.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
CAMPHOR (SYNTHETIC)INACTIVE INGREDIENT5TJD82A1ET1
DIBUCAINE HYDROCHLORIDEINACTIVE INGREDIENTZ97702A5DG1
DIPHENHYDRAMINE HYDROCHLORIDEINACTIVE INGREDIENTTC2D6JAD401
MENTHOLINACTIVE INGREDIENTL7T10EIP3A1

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
68994-200168994-2001-1

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
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
DIPHENHYDRAMINE HYDROCHLORIDETC2D6JAD40IACT
DIBUCAINE HYDROCHLORIDEZ97702A5DGIACT

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 · 26 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MENTHOLMENTHOLL7T10EIP3ALOTION / TOPICAL0.05 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASUSPENSION / ORAL1 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3APOWDER, FOR SOLUTION / ORALNAExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACREAM / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / NASAL40.32 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / ORAL3 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION, CONCENTRATE / ORAL0.5 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, SPRAY / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AINHALANT / NASAL32 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ADROPS / OPHTHALMICNAExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / SUBLINGUAL2 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGEL / TOPICAL0.1 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETJELLY / NASAL65 mgExact identifier — unii candidate
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET / ORAL0.58 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ATABLET, ORALLY DISINTEGRATING / ORAL14 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACAPSULE / ORAL0.87 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AJELLY / NASAL32.5 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AMOUTHWASH / BUCCAL0.15 mg/1mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ACONCENTRATE / ORAL0.05 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASYRUP / ORAL7.5 mg/5mlExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3APASTE, DENTIFRICE / DENTAL4.7 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
CAMPHOR (SYNTHETIC)CAMPHOR (SYNTHETIC)5TJD82A1ETDROPS / OPHTHALMICNAExact identifier — unii candidate
2 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOAP / TOPICAL0.75 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AGUM, CHEWING / BUCCAL89 mgExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3AAEROSOL, METERED / RESPIRATORY (INHALATION)0.02 %w/wExact identifier — unii candidate
24 equally ranked IID candidates
MENTHOLMENTHOLL7T10EIP3ASOLUTION / DENTALNAExact identifier — unii candidate
24 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
05999698-c1da-4f28-a82e-1ca80271eb8cbdc48a36-d6da-4ecf-a2a7-fe9ef9049f002014-05-16WarningsExact identifier
spl id: 05999698-c1da-4f28-a82e-1ca80271eb8c
spl set id: bdc48a36-d6da-4ecf-a2a7-fe9ef9049f00

Reported adverse events (FAERS/openFDA)#

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