LIDOREAL PATCH - lidocaine and menthol patch 
FORREAL PHARMACEUTICALS LLC

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LidoReal Patch

Drug Facts

Active Ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Active Ingredient

Menthol 1%

Purpose

Topical Analgesic

Uses

For the temporary relief of pain.

Warnings

For external use only

Do not use

  • on the face or rashes, on wounds or damaged skin
  • in the eyes, mouth, or other mucous membranes
  • on genitals
  • with a heating pad
  • right before or after heart surgery
  • any patch from a pouch that has been opened for 7 or more days
  • in large quantities, particularly over raw surfaces or blistered areas
  • if tamper-evident seal is torn, broken, or missing
  • more than 2 patches per day unless directed by a doctor
  • children under 18 years of age

Ask a doctor before use if you have

  • allergies to topical products
  • high blood pressure, heart disease, or kidney disease.

When using this product

  • avoid contact with eyes. If eye contact occurs, rinse thoroughly with water
  • the risk of heart attack or stroke may increase if you use more than directed or for longer than directed.

Stop use and consult a doctor if

condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days.

If pregnant or breast feeding, ask a health professional before use.

Do not use during last 3 months of pregnancy because it may cause problems in the unborn child or complications during delivery.

Keep out of reach of children.

If put in mouth, seek medical help or contact a Poison Control Center right away. Dispose of the used patches by folding sticky ends together.

Directions

Adults 18 years and older:

Other information

Inactive Ingredients

dihydroxyaluminum aminoacetate, edetate disodium, glycerin, hydroxyacetophenone, kaolin, mineral oil, polyacrylic acid, polusorbate 80, polyvinyl pyrrolidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions?

877-367-3250

Principal Display Panel

NDC 81877-725-15

Forreal Pharmaceuticals
YOUR SOLUTION TO BETTER HEALTHCARE.

LIDOREAL

Lidocaine 4% and Menthol 1% Patch

15 PATCHES

10 cm x 14 cm each

LidoPro Patch

LIDOREAL PATCH  
lidocaine and menthol patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-725
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE4 mg
MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A) MENTHOL1 mg
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)  
KAOLIN (UNII: 24H4NWX5CO)  
MINERAL OIL (UNII: T5L8T28FGP)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
POVIDONE K90 (UNII: RDH86HJV5Z)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81877-725-1515 in 1 BOX; Type 0: Not a Combination Product05/15/2024
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01705/15/2024
Labeler - FORREAL PHARMACEUTICALS LLC (118029197)

Revised: 5/2024
Document Id: 18bfb811-a8d5-483b-9faf-ef6cf4215a86
Set id: 19f1c037-b4b8-47b0-b0f9-036691c1d307
Version: 1
Effective Time: 20240517
 
FORREAL PHARMACEUTICALS LLC