PUREGEN LABS PAIN RELIEF 4 LIDOCAINE- lidocaine patch 
Advanced Rx LLC

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PUREGEN LABS Pain Relief 4% Lidocaine Patch

Drug Facts

Active ingredient

Lidocaine 4.00 %

Purpose

Topical Anesthetic

Uses:

Warnings:

For external use only.

Do not use

  • more than 1 patch at a time
  • on wounds or damaged skin
  • with a heating pad
  • If you are allergic to any ingredients of this product

When using this product

  • Avoid contact with the eyes

Stop use and ask a doctor if

  • localized skin reactions occur, such as rash, itching, redness, irritation
  • condition worsens, or if
  • symptoms persist for more than 7 days or clear up and occur again within a few days.

Keep out of reach of children.

If swallowed, get medical help, or contact a Poison Control Center right away.

If pregnant or breast-feeding,

ask a health professional before use

Directions:

Other information:

Inactive ingredients

Aqua (Deionized Water), Dihydroxyaluminum Aminoacetate, Disodium EDTA, Glycerin, Methylparaben, Polyvinyl Alcohol, Propylene Glycol, Propylparaben, Sodium Carboxymethyl Cellulose, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide

Questions?

call toll-free 1-800-630-8895

Package Labeling:

Label

PUREGEN LABS PAIN RELIEF 4 LIDOCAINE 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:80513-814
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
WATER (UNII: 059QF0KO0R)  
DIHYDROXYALUMINUM AMINOACETATE (UNII: DO250MG0W6)  
EDETATE DISODIUM (UNII: 7FLD91C86K)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED (UNII: K679OBS311)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:80513-814-3030 in 1 BOX06/03/2024
112 g in 1 PATCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01706/03/2024
Labeler - Advanced Rx LLC (042795108)

Revised: 6/2024
Document Id: 1a99684d-b57c-8eac-e063-6294a90aae2e
Set id: 9dff40d8-8d7e-4629-bea5-987f5e68477d
Version: 1
Effective Time: 20240611
 
Advanced Rx LLC