Label: PASMOL PAIN RELIEVING- menthol and methyl salicylate cream

  • 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 April 8, 2015

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  • Active ingredients

    Menthol 5%

    Methyl Salicylate 14%

  • Purpose

    Pain Relieving

  • Uses

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

    • Arthritis
    • simple backache
    • bruises
    • sprains
  • Warnings

    For external use only.

    Do not use

    • in the eyes
    • on mucous membranes
    • on wounds or damaged skin

    When using this product

    • do not bandage tightly

    Stop use and ask a doctor if

    • condition worsens or symptoms persist for more than 7 days or clear up and occur again within a few day

    • redness is present

    • excessive irritation of the skin develops

    Keep out of reach of children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • Adults and children three years of age and older: apply to affected area not more than 3-4 times daily.
    • Children under 3 years of age: consult a doctor
  • Inactive ingredients

    PETROLATUM

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED BY GRAFOR INC. 1360 CASTELLANAS ST LA RAMBLA PONCE, PR 00730 UNITED STATES (787) 842-1423 WWW.PASMOL.COM REPORT ADVERSE EVENTS TO GRAFOR INC.

  • Pasmol Pain Relieving Ointment, 85g (61361-820-03)

    PASMOL

    “Arthritis Formula”

    “Formula Artritis”

    Pain Relieving Ointment

    Net Wt./ Peso Neto 3 oz (85 g)

    Label

  • INGREDIENTS AND APPEARANCE
    PASMOL PAIN RELIEVING 
    menthol and methyl salicylate cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61361-820
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL5 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE14 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:61361-820-0385 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart34804/08/2015
    Labeler - Grafor, Inc. (135138811)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grafor, Inc.135138811manufacture(61361-820)
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