Label: METHYL SALICYLATE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated July 15, 2025

If you are a consumer or patient please visit this version.

View All Sections
  • Drug Facts

  • Active Ingredient                                               Purpose

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

  • PURPOSE

  • Uses

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

    • simple backache
    • lumbago
    • arthritis
    • neuralgia
    • strains
    • bruises
    • sprains
  • Warnings

    For external use only.

  • When using this product

    • 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

    • 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.

    If swallowed, get medical help or contact a Poison Control Center right away.

  • DOSAGE & 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

  • Other Information

    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

    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

  • QUESTIONS

    Questions?Call 877-227-3137

  • PRINCIPAL DISPLAY PANEL

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

    Carton Label

    carton-label

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

    Box Label

    box-label

    Manufactured For:

    ViolaCare, Inc.

    Parsippany, New Jersey, 07054

  • INGREDIENTS AND APPEARANCE
    METHYL SALICYLATE 
    methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:85231-201
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE25 g  in 60 g
    Inactive Ingredients
    Ingredient NameStrength
    C13-14 ISOPARAFFIN (UNII: E4F12ROE70)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CHONDROITIN SULFATE SODIUM, SHARK (UNII: Q75WVO004L)  
    ETHYLHEXYLGLYCERIN (UNII: 147D247K3P)  
    GLUCOSAMINE SULFATE POTASSIUM CHLORIDE (UNII: 15VQ11I66N)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    ISOSTEARIC ACID (UNII: X33R8U0062)  
    LAURETH-7 (UNII: Z95S6G8201)  
    PEG-100 MONOSTEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    POLYACRYLAMIDE (1500 MW) (UNII: 5D6TC4BRWV)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:85231-201-601 in 1 CARTON06/02/2025
    160 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM01706/02/2025
    Labeler - ViolaCare, Inc. (119452160)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!