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Parche Leon Milagroso

Dosage form: patch
Ingredients: CAPSAICIN 0.025g in 100g, CAMPHOR (SYNTHETIC) 3g in 100g, MENTHOL 1.25g in 100g
Labeler: Pharmadel LLC
NDC Code: 55758-017

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Parche Leon Milagroso Hot Patch

Drug Facts

Active Ingredient

Capsaicin 0.025%

Camphor 3.00%

Menthol 1.25 %

Purpose

External Analgesic

Uses

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

  • simple backache
  • arthritis
  • strains
  • sprains

Warnings

FOR EXTERNAL USE ONLY. Avoid contact with eyes.

ALLERGY ALERT:

This product contains natural rubber latex which may cause allergy reactions.

Do not use
  • on children under 12 years of age except on the advice of a physician
  • on wounds or damaged skin or very sensitive skin
  • with bandage
  • with a heating pad or apply external heat
  • if you are allergic to any ingredients of this product

When using this product
  • do not use other than directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage or cover with any type of wrap except clothing
  • discontinue use at least 1 hour before a bath or shower
  • do not use immediately after a bath or shower

Stop use and ask a doctor if
  • muscle aches and pains persist for more than 7 days
  • condit ion worsen
  • rash, itching, or excessive irritation of skin occurs
  • if symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN.

In case accidental ingestion, get medical help or contact a Poision Control Center right away.

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

TAMPER EVIDENT:

Do not use if packet containing the patch is torn or broken

Directions
  • adults & children 12 yrs of age & older: apply to affected area not more than 3 to 4 times daily
  • children under 2 year 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

Inactive ingedients

antioxidants, cycloalkyl process oil, rosin ester resins, styrene block copolymers

Questions & comments?

1-899-359-3478 (M-F) 9 AM to 5 PM Eastern or www.pharmadelusa.com

For the Temporary Relief of:

  • Back Pain
  • Muscular Pain
  • Joint Pain

External Analgesic

PARCHE LEON MILAGROSO 
capsaicin, camphor, menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55758-017
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CAPSAICIN (CAPSAICIN) CAPSAICIN0.025 g  in 100 g
CAMPHOR (SYNTHETIC) (CAMPHOR (SYNTHETIC)) CAMPHOR (SYNTHETIC)3 g  in 100 g
MENTHOL (MENTHOL) MENTHOL1.25 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ROSIN 
STYRENE 
Packaging
#Item CodePackage Description
1NDC:55758-017-1212 POUCH in 1 CARTON
12.27 g in 1 POUCH
2NDC:55758-017-066 POUCH in 1 CARTON
22.27 g in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart34812/05/2014
Labeler - Pharmadel LLC (026095439)

Revised: 01/2017
 
Pharmadel LLC

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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