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

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

  • Active ingredients

    Menthol 5%

    Methyl Salicylate 14%

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  • Purpose

    Pain Relieving

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  • Uses

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

    • Arthritis
    • simple backache
    • bruises
    • sprains
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  • 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.

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  • 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
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  • Inactive ingredients

    PETROLATUM

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  • 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.

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  • 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

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  • INGREDIENTS AND APPEARANCE
    PASMOL PAIN RELIEVING 
    menthol and methyl salicylate cream
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:61361-820
    Route of Administration TOPICAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g  in 100 g
    METHYL SALICYLATE (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ) METHYL SALICYLATE 14 g  in 100 g
    Inactive Ingredients
    Ingredient Name Strength
    PETROLATUM (UNII: 4T6H12BN9U)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:61361-820-03 85 g in 1 JAR; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC MONOGRAPH NOT FINAL part348 04/08/2015
    Labeler - Grafor, Inc. (135138811)
    Establishment
    Name Address ID/FEI Business Operations
    Grafor, Inc. 135138811 manufacture(61361-820)
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