Label: TOPICAL ANALGESIC- methyl salicylate ointment

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated March 3, 2023

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  • Active Ingredient(s)

    Methyl Salicylate 15% . Purpose: Topical Analgesic

  • Purpose

    Topical Analgesic

  • Use

    For temporary relief of minor aches and pains of muscles and joints associated with simple backache, arthritis, strains, bruises and sprains.

  • Warnings

    For external use only. Avoid Contact with the eyes. Do not bandage tightly or apply to wounds or damaged costs.

  • Do not use

    • On children under 16 years of age except on the advice of the physician.
  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

  • PREGNANCY

    If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case accidental ingestion, get medical help or contact a Poision Control Center right away.

  • Directions

    Adults and children 16 years of age and older: Wash the affected area with mild soap and warm water and rinse thoroughly. Apply to affected area not more than 3 to 4 times daily.

    Do not bandage tightly or apply to wounds or damaged skin. Children under 16 years of age; consult a doctor.

  • Other information

    • Store between 15-30C (59-86F)
    • Avoid freezing and excessive heat
  • Inactive ingredients

    Arnica, camphor, eucalyptus oil, D&C brown #486. Menthol, Mineral Oil, Paraffin Wax, Propylparaben, Tea Tree Oil, White Petrolatum

  • STOP USE

    condition worsens, or if symptoms persist for more than 7 days or clear up and occur again with a few days.

  • Package Label - Principal Display Panel

    2.5oz label2.5oz

  • INGREDIENTS AND APPEARANCE
    TOPICAL ANALGESIC 
    methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:82165-100
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE15 mg  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WHITE PETROLATUM (UNII: B6E5W8RQJ4)  
    CAMPHOR (SYNTHETIC) (UNII: 5TJD82A1ET)  
    WATER (UNII: 059QF0KO0R)  
    ARNICA MONTANA (UNII: O80TY208ZW)  
    EUCALYPTUS OIL (UNII: 2R04ONI662)  
    MENTHOL (UNII: L7T10EIP3A)  
    MINERAL OIL (UNII: T5L8T28FGP)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    TEA TREE OIL (UNII: VIF565UC2G)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:82165-100-0270 g in 1 JAR; Type 0: Not a Combination Product05/15/2021
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/15/2021
    Labeler - Dermaline USA Corp (016069241)
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