LIDOCAINE- lidocaine patch 
FORREAL PHARMACEUTICALS LLC

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Lidocaine 4%

Lidocaine 4%

Topical Anesthetic

For the temporary relief of pain

For external use only

Do not use

When using this product

Stop use and ask a doctor if

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 and children 12 years of age and over:

​Children under 12 years of age: Consult a doctor

Other information:

Other ingredients: Acrylic Adhesive, Flaxseed oil, and Polysorbate 80

Questions or comments? 866-747-7365

Packaged For:

Forreal Pharmaceuticals LLC

Royal Oak, MI 48067

Questions or Comments please call 877-367-3250

NDC 81877-514-15

Qty:15 Patches

(5 per Resealable Pouch) x 3

Lidocaine 4%

Topical Pain Patch

for temporary pain relief

PRINCIPAL DISPLAY PANEL

LIDOCAINE 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:81877-514
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
BUTYLATED HYDROXYTOLUENE (UNII: 1P9D0Z171K)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
GLYCERIN (UNII: PDC6A3C0OX)  
SORBITOL (UNII: 506T60A25R)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)  
KAOLIN (UNII: 24H4NWX5CO)  
SILODRATE ANHYDROUS (UNII: 59110L5W24)  
2-ETHYLHEXYL ACRYLATE (UNII: HR49R9S6XG)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYACRYLIC ACID (250000 MW) (UNII: 9G2MAD7J6W)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
WATER (UNII: 059QF0KO0R)  
SODIUM POLYACRYLATE (2500000 MW) (UNII: 05I15JNI2J)  
SORBITAN SESQUIOLEATE (UNII: 0W8RRI5W5A)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
UREA (UNII: 8W8T17847W)  
Product Characteristics
Color    Score    
ShapeRECTANGLE (White Flexible Patch) Size
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81877-514-153 in 1 BOX06/27/2022
11 g in 1 POUCH; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/27/2022
Labeler - FORREAL PHARMACEUTICALS LLC (118029197)

Revised: 1/2023
Document Id: 2b6781f5-573a-41cb-a5c9-827c6af89b5b
Set id: 14edf7dc-c5dc-4b74-b583-0f87529f4536
Version: 2
Effective Time: 20230110
 
FORREAL PHARMACEUTICALS LLC