Kevueno Pain Relieving
FDA Label NDC 59478-000

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Prilumar Laboratorios for the product Kevueno Pain Relieving (NDC 59478-000). 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 kevueno pain relieving ointment, active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Keep Out Of Reach Of Children

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

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