Label: BALSAMO DE UBRE MASCURA- 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 February 18, 2022

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

View All Sections
  • Active Ingredient 

    Methyl Salicylate 10.5 % ............................................Topical Analgesic

  • Uses

    Topical Analgesic

  • Uses

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

  • Warnings

    For external use only.

    Avoid contact with the eyes.

    Do not use otherwise than as directed

  • Do not use    with a heating pad

    • with a bandage
    • on wounds or dasmage skin
    • over extensive areas of the body
    • with a heating pad
    • on a child under 12 years of age
    • on irritated skin
  • Stop use and ask a doctor immediately if

    • pain persists for more than 7 days, redness is present, or in conditions affecting children under 12 years of age
    • excessive irritation of skin develops
    • condition worsens
  • If pregnant or breast-feeding,

    ask a health professional before use.

  • Keep out of reach of children to avoid accidental poisoning.

    If swallowed, induce vomiting and call a physician or contact a Poison Control Center right away.

  • Directions

    • Adults and Children 12 years and older: apply generously and gently massage into painful area until the product disappears. Apply into affected area not more than 3 to 4 times daily
    • Children under 12 years of age: ask a doctor
  • Other Information

    Store at 15° C to 25° C (59° F to 77° F)

  • Inactive ingrediets 

    camphor, D&C yellow #10, menthol, methylparaben, paraffin wax, propylparaben, white petrolatum.

  • Questions?

    call 1-800-560-5223 M-F 9 AM to 4 PM Eastern

  • PRINCIPAL DISPLAY PANEL

    balsamo mascurabalsamo mascura2

  • INGREDIENTS AND APPEARANCE
    BALSAMO DE UBRE  MASCURA
    methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:53145-401
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE10.5 g  in 90 g
    Inactive Ingredients
    Ingredient NameStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    MENTHOL (UNII: L7T10EIP3A)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PARAFFIN (UNII: I9O0E3H2ZE)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:53145-401-0390 g in 1 CONTAINER; Type 0: Not a Combination Product05/10/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34805/10/2011
    Labeler - Menper Distributors Inc. (101947166)
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!