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Balsamo de Ubre (Pharmalab Enterprises Inc.)

Available Formats

Dosage Form Package Information Links
OINTMENT 150 g in 1 JAR (14505-263-05) Label Information
OINTMENT 90 g in 1 CONTAINER (14505-263-03) Label Information

Complete Balsamo de Ubre Information

  • ACTIVE INGREDIENT

    Active Ingredient                                              Purpose

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


  • PURPOSE

    Uses

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

  • WARNINGS

    Warnings

    For external use only

    Do not use otherwise than as directed


  • DO NOT USE


    Do not use

    • with a heating pad
    • with a tight bandage
    • on eyes, mucous membranes, broken or irritated skin
    • over extensive areas of the body
    • on a child under 12 years of age

  • STOP USE

    Stop use and ask a doctor immediately if

    • pain persists for more than 7 days, or redness is present, or in conditions affecting children under 12 years of age
    • excessive irritation of skin develops

  • PREGNANCY OR BREAST FEEDING

    If pregnant or breast-feeding, ask a health professional before use.


  • KEEP OUT OF REACH OF CHILDREN

    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.


  • DOSAGE & ADMINISTRATION

    Directions

    • Adults and Children 12 years and older: apply generously and gently massage into painful area until the product disappears. Repeat 3 to 4 times daily
    • Children under 12 years of age: ask a doctor

  • INDICATIONS & USAGE

    Other Information

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

  • INACTIVE INGREDIENT

    Enter section text here


  • QUESTIONS

    Questions? call 1-800-560-5223


  • INGREDIENTS AND APPEARANCE
    BALSAMO DE UBRE   MASCURA
    methyl salicylate ointment
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:14505-263
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    METHYL SALICYLATE (UNII: LAV5U5022Y) (METHYL SALICYLATE - UNII:LAV5U5022Y) METHYL SALICYLATE 10.5 g  in 90 g
    Inactive Ingredients
    Ingredient Name Strength
    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 Code Package Description Marketing Start Date Marketing End Date
    1 NDC:14505-263-03 90 g in 1 CONTAINER
    2 NDC:14505-263-05 150 g in 1 JAR
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part348 05/10/2011
    Labeler - Pharmalab Enterprises Inc. (174401088)
    Registrant - Pharmalab Enterprises Inc. (174401088)
    Establishment
    Name Address ID/FEI Business Operations
    Pharmalab Enterprises Inc. 174401088 manufacture