Label: PARCHE LEON MILAGROSO DUAL ACTION- capsaicin, menthol patch
- NDC Code(s): 55758-046-06
- Packager: Pharmadel LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: OTC monograph not final
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.
Updated July 1, 2016
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- Drug Facts
- Active Ingredients
FOR EXTERNAL USE ONLY. Avoid contact with the eyes.
Allergy Alert: This product contains natural rubber latex which may cause allergy reactions.
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 or clear up and occur again within a few days
- redness is present
- KEEP OUT OF REACH OF CHILDREN.
- 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 ingredients:
- Other information:
- Questions & comments?
- PRINCIPAL DISPLAY PANEL
INGREDIENTS AND APPEARANCE
PARCHE LEON MILAGROSO DUAL ACTION
capsaicin, menthol patch
Product Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:55758-046 Route of Administration TOPICAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL 5 g in 100 g CAPSAICIN (UNII: S07O44R1ZM) (CAPSAICIN - UNII:S07O44R1ZM) CAPSAICIN 0.0375 g in 100 g Inactive Ingredients Ingredient Name Strength EDETATE DISODIUM (UNII: 7FLD91C86K) DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4) SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J) METHYLPARABEN (UNII: A2I8C7HI9T) IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB) GLYCERIN (UNII: PDC6A3C0OX) ALOE VERA LEAF (UNII: ZY81Z83H0X) POLYSORBATE 80 (UNII: 6OZP39ZG8H) PROPYLPARABEN (UNII: Z8IX2SC1OH) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:55758-046-06 6 in 1 CARTON 02/01/2016 1 2.27 g in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part348 02/01/2016 Labeler - Pharmadel LLC (026095439)