Lekon Pain Relief Oil
FDA Label NDC 85954-001

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cai Industries Corp. for the product Lekon Pain Relief Oil (NDC 85954-001). 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, directions, inactive ingredients, product label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Menthol 5%

Purpose

External analgesic

Uses

Temporarily relieves muscle and joint pains: backaches, arthritis, strains, bruises, sprains

Warnings

For external use only

When using this product 

  • avoid contact with the eyes or mucous membranes 
  • do not use on wounds or broken skin

    • Stop use and ask a doctor if

    • conditions worsen 
    • excessive skin irritation develops
    • nausea, vomiting, abdominal discomfort, diarrhea, or a skin rash occurs
    • symptoms persists for more than 7 days

      • If pregnant or breast-feeding, ask a doctor 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 few drops into palm or hand nad massage into affected areas 
  • Children under 12 years of age: consult your physician

Inactive Ingredients

CLEMATIS TERNIFLORA VAR. MANDSHURICA ROOT, MOMORDICA COCHINCHINENSIS SEED, RICINUS COMMUNIS SEED, MYRRH, FRANKINCENSE, METHYL SALICYLATE

Product Label

Image Description (Label2)

Image Description (Label2)

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