FDA.reportPublic FDA data

Methyl Salicylate 25_Percent Pump Cream

Manufacturer
Alexso, Inc
Effective date
2024-05-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:12:49

Label at a glance#

ProductMethyl Salicylate 25 Percent
Active ingredientMETHYL SALICYLATE
Label structure9 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Dosage and administration

 adults and children 2 years and older apply externally to the affected area up to 3 to 4 times a day  children under 2 years  ask a doctor

Storage and handling

May be applied under occlusive dressing. Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Methyl Salicylate 25% Pump Bottle Cream 

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, such as simple backache, lumbago, arthritis, neuralgia, strains, bruises, and sprains.

Warnings

WARNINGS SECTION

​For external use only.

When using this product

OTC - WHEN USING SECTION

  • Avoid contact with the eyes
  • Do not use in large quantities, particularly over raw surfaces or blistered areas
  • Do not apply to wounds or damaged skin
  • Do not bandage

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

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 and olderapply externally to the affected area up to 3 to 4 times a day
 children under 2 years ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • May be applied under occlusive dressing.
  • Store at 20-25°C (68-77°F); excursions permitted to 15-30°C (59-86°F).  See USP Controlled Room Temperature.

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aqua (Deionized Water), Arnica Montana Flower Extract, Indian Frankincense, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Monostearate, Cetostearyl Alcohol, Aloe Vera Leaf, C13-14 Isoparaffin, Isostearyl Palmitate, Trolamine, Laureth-7, PEG-100 Stearate, Phenoxyethanol, Propylene Glycol, Stearic Acid.

Methyl Salicylate 25% Pump Bottle Cream

NDC: 50488-1016-5

50 mL

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

Tel: 888.495.6078

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 50488-1016-5
Methyl Salicylate 25% Pump Bottle Cream
50 mL

Rev 05/24

NDC 50488-1016-5 Methyl Salicylate 25% Pump Bottle Cream 50 mL Rev 05/24NDC 50488-1016-5 Methyl Salicylate 25% Pump Bottle Cream 50 mL Rev 05/24

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238542methyl salicylate 25 % Topical CreamPSN1
238542methyl salicylate 250 MG/ML Topical CreamSCD1
238542methyl salicylate 25 % Topical CreamSY1

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1016-5Methyl Salicylate 25 Percent50 mL in 1 BOTTLE, PUMPCREAM501

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50488-1016METHYL SALICYLATE 25 PERCENT (METHYL SALICYLATE) CREAM [ALEXSO, INC]1Current NDC, 1 package rows20240522_d8b8b0ba-69e9-4965-bf9b-6db21db69b34.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1016-5ML - Milliliter50488-1016bf43cf6a-cb28-4752-8ffa-6260e7ce719412024-08-12

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50488-101650488-1016-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
INDIAN FRANKINCENSE4PW41QCO2MIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
ALOE VERA LEAFZY81Z83H0XIACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
TROLAMINE9O3K93S3TKIACT
LAURETH-7Z95S6G8201IACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT

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
Methyl Salicylate 25 PercentMETHYL SALICYLATEAlexso, Incd8b8b0ba-69e9-4965-bf9b-6db21db69b342024-05-23WarningsExact identifier
ndc (package): 50488-1016-5
ndc (product): 50488-1016
ndc11 (package): 50488101605
spl id: 78bef856-b769-49ad-89af-8e46966e99ec
spl set id: d8b8b0ba-69e9-4965-bf9b-6db21db69b34

Reported adverse events (FAERS/openFDA)#

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