FDA.reportPublic FDA data

GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back

Manufacturer
Geri-Gentle Corporation
Effective date
2023-11-10
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:59:57

Label at a glance#

ProductGeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back
Active ingredientLIDOCAINE
Label structure7 sections

Indications and uses

For temporary relief of pain

Dosage and administration

Adults and children over 12 years: Clean and dry affected area. remove film from patch and apply to skin apply 1 patch at a time to affected area, not more than 3 to 4 times daily. wear each patch up to 8 hours maximum. consult a physcian Children 12 years or younger:

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of pain

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

OTC - WHEN USING SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health care professional before use.

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 12 years:

  • Clean and dry affected area.
  • remove film from patch and apply to skin
  • apply 1 patch at a time to affected area, not more than 3 to 4 times daily.
  • wear each patch up to 8 hours maximum.
  • consult a physcian Children 12 years or younger:

Other information:

SPL UNCLASSIFIED SECTION

  • Avoid storing product in direct sunlight
  • Protect product from excessive moisture

Inactive ingredients:

INACTIVE INGREDIENT SECTION

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

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner PackageLabel0Label0

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69771-010-05GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back0.0242 mL in 1 PACKAGEPATCH0.02423
69771-010-05GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine Back4 in 1 POUCHPATCH43

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-010GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH 4 LODOCAINE BACK (LIDOCAINE) PATCH [GERI-GENTLE CORPORATION]3Current NDC, Legacy NDC, 2 package rows20231111_e4427928-c063-9ca6-e053-2995a90a1aa1.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-01069771-010-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
GLYCERINPDC6A3C0OXIACT
KAOLIN24H4NWX5COIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
TARTARIC ACIDW4888I119HIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
GeriGentle FrostyHeat Pain Relief Patch 4 Lodocaine BackLIDOCAINEGeri-Gentle Corporatione4427928-c063-9ca6-e053-2995a90a1aa12023-11-10WarningsExact identifier
ndc (package): 69771-010-05
ndc (product): 69771-010
ndc11 (package): 69771001005
spl id: 09cc536e-d4d7-7786-e063-6294a90a7f16
spl set id: e4427928-c063-9ca6-e053-2995a90a1aa1

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.