Pasmol Pain Relieving
FDA Label NDC 61361-820

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Grafor, Inc. for the product Pasmol Pain Relieving (NDC 61361-820). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Other

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 (Label)

Label (Label)

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