BALSAMO DE UBRE (METHYL SALICYLATE) OINTMENT [MENPER DISTRIBUTORS INC.]

BALSAMO DE UBRE (METHYL SALICYLATE) OINTMENT [MENPER DISTRIBUTORS INC.]
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NDC 53145-401-03
Set ID fb7b3611-4dc7-49be-a1a7-c8d5534af18b
Category HUMAN OTC DRUG LABEL
Packager Menper Distributors Inc.
Generic Name
Product Class
Product Number
Application Number PART348
  • 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 mascura2balsamo 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)

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