Parche Leon Patch
FDA Label NDC 55758-039

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Pharmadel Llc for the product Parche Leon (NDC 55758-039). 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 drug facts, otc - purpose, uses, warnings, do not use, stop use and ask a doctor if, if pregnant or breast-feeding,, 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

Otc - Purpose

Active ingredients (in each patch) Purpose

Camphor 3%.............................................................

External analgesic

Menthol 1.25%..........................................................

External analgesic

Capsaicin 0.025%.....................................

External analgesic

Uses

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

  • simple back aches
  • arthritis
  • strains
  • sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with the eyes .

Do Not Use

  • on wounds or damaged skin
  • with a bandage or heating pad
  • on sensitive skin
  • if allergic to any ingredients in this product

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms persist for more than 7 days
  • clear up and occur again within a few days
  • redness is present

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

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

Directions

  • adults & children 12 years of age and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: consult a doctor
  • clean and dry affected area
  • remove patch from film
  • apply sticky side of patch to affected area
  • use one patch at a time
  • leave patch on affected area for up to 8-hours at a time

Other Information

  • store at room temperature 59-86°F (15-30°C)
  • do not store in direct sunlight or expose to excessive heat

    • Tamper Evident: Do not use if packet containing the patch is torn or broken.

Questions Or Comments?

1-866-359-3478 (M-F) 9 AM to 5 PM EST or www.pharmadel.com

Principal Display Panel

NDC 55758-039-06

PARCHE LEON

External Analgesic

Penetrating pain relief of:

  • Back Aches
  • Muscles
  • Arthritis

    • 6 Adhesive Plaster Patches

    4.72 in x 7.07 in (12 cm x 18 cm)

    Pain Relieving

    HOT PATCH

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