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  5. Label Information: Parche Leon

FDA Label for Parche Leon

View Indications, Usage & Precautions

Table of Contents

    1. DRUG FACTS
    2. OTC - PURPOSE
    3. USES
    4. WARNINGS
    5. DO NOT USE
    6. STOP USE AND ASK A DOCTOR IF
    7. IF PREGNANT OR BREAST-FEEDING,
    8. KEEP OUT OF REACH OF CHILDREN.
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. QUESTIONS OR COMMENTS?
    13. PRINCIPAL DISPLAY PANEL

Parche Leon Product Label

The following document was submitted to the FDA by the labeler of this product Pharmadel Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.