FDA.reportPublic FDA data

Methyl Salicylate 25% Cream

Manufacturer
MARCELLA HEALTH
Effective date
2025-04-14
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:59:30

Label at a glance#

ProductMethyl Salicylate 25% Cream
Active ingredientMETHYL SALICYLATE
Label structure8 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#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%

Purpose

OTC - PURPOSE SECTION

External 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 larger 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 the 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 yearsask 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

Aloe barbadensis leaf extract, cetyl alcohol, glyceryl stearate SE, mineral oil, PEG-100 stearate, peppermint oil, phenoxyethanol, propylene glycol, purified water, stearyl alcohol, white petrolatum, xanthan gum.

MANUFACTURED FOR:
Marcella Health

Cheyene, WY 82001
Questions or Comments
(307) 410-3813 or info@marcellahealth.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Drug Facts:

Methyl Salicylate BoxMethyl Salicylate Box

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 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
85096-001-42Methyl Salicylate 25% Cream120 g in 1 TUBECREAM1201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
85096-001METHYL SALICYLATE 25% CREAM (METHYL SALICYLATE) CREAM [MARCELLA HEALTH]1Current NDC, 1 package rows20250424_32c153c7-de30-504e-e063-6294a90a4020.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85096-001-42GM - Gram85096-00137a85725-90b7-4f06-b4bc-b9b42ec7a07412025-06-13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85096-00185096-001-42

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
XANTHAN GUMTTV12P4NEEIACT
MINERAL OILT5L8T28FGPIACT
PEPPERMINT OILAV092KU4JHIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
CETYL ALCOHOL936JST6JCNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PEG-100 STEARATEYD01N1999RIACT
WATER059QF0KO0RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
METHYL SALICYLATELAV5U5022YACTIB

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% CreamMETHYL SALICYLATEMARCELLA HEALTH32c153c7-de30-504e-e063-6294a90a40202025-04-14WarningsExact identifier
ndc (package): 85096-001-42
ndc (product): 85096-001
ndc11 (package): 85096000142
spl id: 32c14a91-f746-7cfb-e063-6394a90a7901
spl set id: 32c153c7-de30-504e-e063-6294a90a4020

Reported adverse events (FAERS/openFDA)#

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