FDA.reportPublic FDA data

Banalg

Manufacturer
Rebel Distributors Corp
Effective date
2011-02-15
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:27:51

Label at a glance#

ProductBanalg
Active ingredientMETHYL SALICYLATE, MENTHOL
Label structure5 sections

Indications and uses

For the temporary relief of minor ach3es and pains of muscles and joints associated with arthritis and rheumatism. Also good for simple backache, strains and sprains.

Dosage and administration

Apply fast vanishing lotion with gentle massage to affected area not more than 3 to 4 times daily.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 14.0%

Menthol 3.0%

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor ach3es and pains of muscles and joints associated with arthritis and rheumatism. Also good for simple backache, strains and sprains.

Warnings

WARNINGS SECTION

Use only as directed. If pain persists more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult your physician immediately. Discontinue use if excessive irritation of the skin develops. Avoid getting into the eyes or on mucous membranes.

For external use only. Use only as directed. Do not apply to wounds, broken or irritated skin. Do not use with a heating pad. Do not bandage tightly.

If swallowed, induce vomiting and contact a physician or poison control center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply fast vanishing lotion with gentle massage to affected area not more than 3 to 4 times daily.

Package/Label Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Banalg Hospital StrengthBanalg Hospital Strength

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
702415Banalg 3 % / 14 % Topical LotionPSN1
311506menthol 3 % / methyl salicylate 14 % Topical LotionPSN1
702415menthol 30 MG/ML / methyl salicylate 140 MG/ML Topical Lotion [Banalg]SBD1
311506menthol 30 MG/ML / methyl salicylate 140 MG/ML Topical LotionSCD1
702415Banalg (menthol 3 % / methyl salicylate 14 % ) Topical LotionSY1
702415Banalg (menthol 30 MG/ML / methyl salicylate 140 MG/ML) Topical LotionSY1
311506menthol 3 % / methyl salicylate 14 % Topical LotionSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
21695-440-022019-09-24C16284748780-1934fe258-4c3e-48b1-e053-8cdaa90a720aBanalg Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21695-440-02Banalg60 g in 1 BOTTLELOTION601

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21695-440BANALG (METHYL SALICYLATE) LOTION [REBEL DISTRIBUTORS CORP]1Legacy NDC, 1 package rows20110428_5b4c09e6-4228-47d5-b8f2-5959f8aede38.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
MENTHOLACTIVE INGREDIENTL7T10EIP3A1
METHYL SALICYLATEACTIVE INGREDIENTLAV5U5022Y1
MENTHOLACTIVE MOIETYL7T10EIP3A1
METHYL SALICYLATEACTIVE MOIETYLAV5U5022Y1
1,3-DIMETHYLBUTYL SALICYLATEINACTIVE INGREDIENT47OL39K42M1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
21695-44021695-440-02
0456-0525

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
MENTHOLL7T10EIP3AACTIB
1,3-DIMETHYLBUTYL SALICYLATE47OL39K42MIACT
WATER059QF0KO0RIACT

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
5b4c09e6-4228-47d5-b8f2-5959f8aede385b4c09e6-4228-47d5-b8f2-5959f8aede382011-02-15WarningsExact identifier
spl id: 5b4c09e6-4228-47d5-b8f2-5959f8aede38
spl set id: 5b4c09e6-4228-47d5-b8f2-5959f8aede38

Reported adverse events (FAERS/openFDA)#

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