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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

Drug Facts

Active ingredients & Purpose

Active ingredients (in each patch) Purpose

Capsicum oleoresin 0.025%.....................................

External analgesic

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

External analgesic

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

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 the eyes.

Keep out of reach of children

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

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

Do not use
  • on wounds or damaged skin
  • sensitive skin
  • if you are allergic to any ingredients of this product

If pregnant or breast-feeding,

ask a health professional before use.

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

Inactive ingedients

distearyl pentaerythritol diphosphite, glyceryl rosinate, light mineral oil, styrene block copolymers

Questions or Comments?

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

Distributed by:

PHARMADEL LLC

Georgetown, DE 19947

MADE IN CHINA

Principal Display Panel

Capsium

Plaster

PARCHE LEON MILAGROSO

For the Temporary Relief of:

BackPain

MuscularPain

JointPain

1 HOT PATCH

1Parche Poroso

External Analgesic Patch

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
GLYCERYL ROSINATE 
STYRENE 
LIGHT MINERAL OIL 
DISTEARYL PENTAERYTHRITOL DIPHOSPHITE 
Packaging
#Item CodePackage Description
1NDC:55758-017-1212 POUCH in 1 CARTON
12.27 g in 1 POUCH
2NDC:55758-017-012.27 g in 1 POUCH
3NDC:55758-017-066 POUCH in 1 CARTON
3NDC:55758-017-012.27 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)

 
Pharmadel LLC

Medically reviewed on Aug 30, 2018

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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