KEVUENO PAIN RELIEVING (CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE) OINTMENT [PRILUMAR LABORATORIOS]

KEVUENO PAIN RELIEVING (CAMPHOR (NATURAL), MENTHOL, METHYL SALICYLATE) OINTMENT [PRILUMAR LABORATORIOS]
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NDC 59478-000-01
Set ID 40961ebb-c851-455b-a4c3-6b14c9f89332
Category HUMAN OTC DRUG LABEL
Packager Prilumar Laboratorios
Generic Name
Product Class
Product Number
Application Number PART348
  • KeVUENO Pain Relieving Ointment


  • Active Ingredients

    Camphor 5%

    Menthol 10%

    Methyl Salicylate 13%

  • Purpose

    Topical Analgesic

  • Uses

    For the temporary relief of minor aches and pains of muscles and joints associated with:

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

    For external use only. Avoid contact with the eyes or mucous membranes.

    When using this product

    • do not apply to wounds or damaged skin
    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens, or if symptoms persist for more than 7 days or clear up and occur within a few days
    • redness is present
    • excessive irritation of the skin develops

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

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

  • Directions

    • Adults and children 12 years of age and older: Apply to the affected area not more than 3 to 4 times daily
    • Children under 12 years of age: Consult a physician.
  • Other information

    store in a cool place.

  • Inactive Ingredients

    petrolatum

  • KeVUENO Pain Relieving Ointment 4oz (59478-000-01)

    KevuenoLabel 2

  • INGREDIENTS AND APPEARANCE
    KEVUENO PAIN RELIEVING 
    camphor (natural), menthol, methyl salicylate ointment
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59478-000
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CAMPHOR (NATURAL) (UNII: N20HL7Q941) (CAMPHOR (NATURAL) - UNII:N20HL7Q941) CAMPHOR (NATURAL)5 g  in 100 g
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL10 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE13 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59478-000-01113 g in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart34809/25/2013
    Labeler - Prilumar Laboratorios (078891414)
    Registrant - Prilumar Laboratorios (078891414)
    Establishment
    NameAddressID/FEIBusiness Operations
    Prilumar Laboratorios078891414manufacture(59478-000)

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