FDA.reportPublic FDA data

Methyl Salicylate 25% Cream

Manufacturer
ViolaCare, Inc.
Effective date
2025-07-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:07:25

Label at a glance#

ProductMethyl Salicylate
Active ingredientMETHYL SALICYLATE
Label structure11 sections

Indications and uses

Temporarily relieves minor aches and pains of muscles and joints due to: simple backache lumbago arthritis neuralgia strains bruises sprains

Label contents#

Full prescribing information#

Active Ingredient                                               Purpose

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate 25%........................................Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor aches and pains of muscles and joints due to:

  • simple backache
  • lumbago
  • arthritis
  • neuralgia
  • strains
  • bruises
  • 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 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.

DOSAGE & ADMINISTRATION SECTION

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

Other Information

SPL UNCLASSIFIED SECTION

May be applied under occlusive dressing

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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

C13-14 isoparaffin, cetearyl alcohol, chondrotin sulfate sodium, Ethylhexylglycerin, glucosamine sulfate potassium chloride, glycerin, glyceryl stearate, isostearic acid, laureth-7, PEG-100 stearate, phenoxyethanol, polyacrylamide, propylene glycol, stearic acid, water

OTC - QUESTIONS SECTION

Questions?Call 877-227-3137

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Methyl Salicylate 25% Cream - NDC 85231-201-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g)

Carton Label

carton-labelcarton-label

Methyl Salicylate 25% Cream - NDC 85231-201-60 - Pain Relieving Cream - Topical Analgesic - 2.11 OZ (60g)

Box Label

box-labelbox-label

Manufactured For:

ViolaCare, Inc.

Parsippany, New Jersey, 07054

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
238542methyl salicylate 25 % Topical CreamPSN2
238542methyl salicylate 250 MG/ML Topical CreamSCD2
238542methyl salicylate 25 % Topical CreamSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
85231-201-60Methyl Salicylate1 in 1 CARTONCREAM12
85231-201-60Methyl Salicylate60 g in 1 TUBECREAM602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
85231-201-60GM - Gram85231-201ce5732a1-39bf-47bd-94ec-445aa6f0e44512025-09-12

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
85231-20185231-201-60

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
C13-14 ISOPARAFFINE4F12ROE70IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHONDROITIN SULFATE SODIUM, SHARKQ75WVO004LIACT
ETHYLHEXYLGLYCERIN147D247K3PIACT
GLUCOSAMINE SULFATE POTASSIUM CHLORIDE15VQ11I66NIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
ISOSTEARIC ACIDX33R8U0062IACT
LAURETH-7Z95S6G8201IACT
PEG-100 MONOSTEARATEYD01N1999RIACT
PHENOXYETHANOLHIE492ZZ3TIACT
POLYACRYLAMIDE (1500 MW)5D6TC4BRWVIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT
WATER059QF0KO0RIACT
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 SalicylateMETHYL SALICYLATEViolaCare, Inc.8f0ba6e7-8aa4-443e-99ae-a255085ddfec2025-07-15WarningsExact identifier
ndc (package): 85231-201-60
ndc (product): 85231-201
ndc11 (package): 85231020160
spl id: 39f7d92d-a262-c69a-e063-6394a90aca0f
spl set id: 8f0ba6e7-8aa4-443e-99ae-a255085ddfec

Reported adverse events (FAERS/openFDA)#

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