GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK- lidocaine patch 
Geri-Gentle Corporation

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GeriGentle FrostyHeat Pain Relief Patch 4% Lodocaine Back

Drug Facts

Active ingredient

Lidocaine 4%

Purpose

Topical anesthetic

Uses

For temporary relief of pain

Warnings:

For external use only

Do not use

  • More than 1 patch at a time
  • on wounds or damaged skin
  • with heating pad
  • if you are allergic to any ingredient of this product.

When using this product

  • use only as directed
  • avoid contact with eyes and mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

  • localized skin reactions, such as rash, itching, redness, pain swelling and blistering develop
  • Condition worsens
  • Symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days.

If pregnant or breast-feeding,

ask a health care professional before use.

Keep out of reach of children and pets.

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

Directions:

Adults and children over 12 years:

Other information:

Inactive ingredients:

Aluminum Glycinate, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PVP, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

Package Labeling:

Outer PackageInner PackageLabel0

GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK 
lidocaine patch
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69771-010
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987) LIDOCAINE40 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS (UNII: 1K713C615K)  
GLYCERIN (UNII: PDC6A3C0OX)  
KAOLIN (UNII: 24H4NWX5CO)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYSORBATE 80 (UNII: 6OZP39ZG8H)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
TARTARIC ACID (UNII: W4888I119H)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69771-010-054 in 1 POUCH07/16/2022
10.0242 mL in 1 PACKAGE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM01707/16/2022
Labeler - Geri-Gentle Corporation (080367686)

Revised: 11/2023
Document Id: 09cc536e-d4d7-7786-e063-6294a90a7f16
Set id: e4427928-c063-9ca6-e053-2995a90a1aa1
Version: 3
Effective Time: 20231110
 
Geri-Gentle Corporation