FDA.reportPublic FDA data

Methyl Salicylate 30 Percent Cream

Manufacturer
Alexso, Inc
Effective date
2026-02-13
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:43:53

Label at a glance#

ProductMethyl Salicylate 30 Percent Cream
Active ingredientMETHYL SALICYLATE
Label structure10 sections

Indications and uses

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, 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

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

​Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 30%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of minor aches and pains of muscles and joints, associated with simple backache, arthritis, 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 tightly

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

  • 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, Boswellia Serrata Extract, Cetearyl Alcohol, Chondroitin Sulfate, Ethylhexylglycerin, Glucosamine Sulfate, Glycerin, Glyceryl Stearate, C13-14 Isoparaffin, Isostearyl Palmitate, Laureth-7, Methylsulfonylmethane (MSM), PEG-100 Stearate, Phenoxyethanol, Polyacrylamide, Propylene Glycol, Sodium Polyacrylate, Stearic Acid, Triethanolamine

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methyl Salicylate 30% Cream

NDC: 50488-1030-6

60 grams

Methyl Salicylate 30% Cream NDC: 50488-1030-6 60 gramsMethyl Salicylate 30% Cream NDC: 50488-1030-6 60 grams

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methyl Salicylate 30% Cream

NDC: 50488-1030-1

120 grams

Manufactured for:
Alexso, Inc
Los Angeles, CA 90064

Methyl Salicylate 30% Cream NDC: 50488-1030-1 120 grams Manufactured for: Alexso, Inc Los Angeles, CA 90064Methyl Salicylate 30% Cream NDC: 50488-1030-1 120 grams Manufactured for: Alexso, Inc Los Angeles, CA 90064

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
240442methyl salicylate 30 % Topical CreamPSN2
240442methyl salicylate 300 MG/ML Topical CreamSCD2
240442methyl salicylate 30 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50488-1030-1Methyl Salicylate 30 Percent Cream120 g in 1 BOTTLECREAM1202
50488-1030-6Methyl Salicylate 30 Percent Cream60 g in 1 BOTTLECREAM602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50488-1030-1GM - Gram50488-1030e05809c5-4e00-4cc7-b291-cf9effee873212026-05-22
50488-1030-6GM - Gram50488-10309db0fcb4-597f-486a-8ed4-02ca83c0c9d612026-05-22

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50488-103050488-1030-1, 50488-1030-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

Name, UNII, Kind table
NameUNIIKind
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
BOSWELLIA SERRATA GUM4PW41QCO2MIACT
CETEARYL ALCOHOL2DMT128M1SIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL STEARATE230OU9XXE4IACT
C13-14 ISOPARAFFINE4F12ROE70IACT
ISOSTEARYL PALMITATE9EHU0R7ER1IACT
LAURETH-7Z95S6G8201IACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PEG-100 STEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
TRIETHANOLAMINE9O3K93S3TKIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
POLYACRYLAMIDE (10000 MW)E2KR9C9V2IIACT
SODIUM POLYACRYLATE (8000 MW)285CYO341LIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-11-04monthly-update2026-06-03 17:39:06

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 30 Percent CreamMETHYL SALICYLATEAlexso, Inc1d50ccb2-1a5d-49c7-8524-2f54eed63e852026-02-13WarningsExact identifier
ndc (package): 50488-1030-1
ndc (package): 50488-1030-6
ndc (product): 50488-1030
ndc11 (package): 50488103001
ndc11 (package): 50488103006
spl id: 067f696d-8a32-4b4c-bb8e-7109e6ebdb38
spl set id: 1d50ccb2-1a5d-49c7-8524-2f54eed63e85

Reported adverse events (FAERS/openFDA)#

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