FDA.reportPublic FDA data

BAROX S

Manufacturer
Barox Co., Ltd. | Gdkcosmetics Co., Ltd.
Effective date
2017-09-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:52:28

Label at a glance#

ProductBAROX S
Active ingredientCAMPHOR (SYNTHETIC), METHYL SALICYLATE, MENTHOL
Label structure9 sections

Indications and uses

Uses: Barox S is an anti-inflammatory pain relieving and topical analgesic ointment that is intented to relieve muscle and joint pain associated with arthritis, rheumatalgia, backaches, knee pain, shoulder pain.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Active ingredients: L-menthol 0.8%, DL-Camphor 5.9%, Methyl Salicylate 4.6%

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

Inactive Ingredients: Purified Water, Carbomer, Ethanol, Methyl Sulfonylmethane, Methyl Parahydroxybenzoate, Cetyl Palmitate, Avocado Oil, Polysorbate 80, Cetyl Alcohol, Aminomethyl Propanol

PURPOSE

OTC - PURPOSE SECTION

Purpose: Topical Analgesic

WARNINGS

WARNINGS SECTION

Warnings:
For external use only.
Avoid contact with eyes.
Keep this and all drugs out of the reach of children.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs out of the reach of children.

Uses

INDICATIONS & USAGE SECTION

Uses:
Barox S is an anti-inflammatory pain relieving and topical analgesic ointment that is intented to relieve muscle and joint pain associated with arthritis, rheumatalgia, backaches, knee pain, shoulder pain.

Direction

DOSAGE & ADMINISTRATION SECTION

Direction:
Use only as directed. Adults and Children 12 Years of Age and Older: Apply to affected area not more than 3 to 4 times daily.

DESCRIPTION

DESCRIPTION SECTION

DESCRIPTION:

Do not use : on wounds or damage skin

Stop use and ask a doctor Stop use and ask a doctor if excessive skin irritation occurs. Ask a doctor before use if you have redness over the affected area

Other Information : Store in a cool dry place with lid closed tightly

Question Contact : jhs3840@naver.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Image of cartonImage of carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55692-110-012020-01-31C16284748780-19d75b9d0-e44c-f424-e053-dadaa90a57ce9d7f6d85-d94b-4e53-a149-c931088bda0f

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55692-110-01BAROX S120 g in 1 CARTONGEL1202

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55692-110BAROX S (CAMPHOR (SYNTHETIC), METHYL SALICYLATE, MENTHOL) GEL [BAROX CO., LTD.]2Legacy NDC, 1 package rows20170911_9d7f6d85-d94b-4e53-a149-c931088bda0f.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CAMPHOR (SYNTHETIC)ACTIVE INGREDIENT5TJD82A1ET1
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
CAMPHOR (SYNTHETIC)ACTIVE MOIETY5TJD82A1ET1
MENTHOLACTIVE MOIETYL7T10EIP3A1
SALICYLIC ACIDACTIVE MOIETYO414PZ4LPZ1
AVOCADO OILINACTIVE INGREDIENT6VNO72PFC11
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55692-11055692-110-01

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
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
Water059QF0KO0RIACT
AVOCADO OIL6VNO72PFC1IACT

Source Document#

Source XML

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
2f36747a-67ff-4b2f-b7af-ed21d99755459d7f6d85-d94b-4e53-a149-c931088bda0f2017-09-11WarningsExact identifier
spl id: 2f36747a-67ff-4b2f-b7af-ed21d9975545
spl set id: 9d7f6d85-d94b-4e53-a149-c931088bda0f

Reported adverse events (FAERS/openFDA)#

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