FDA.reportPublic FDA data

GeriGentle FrostyHeat Pain Relief Patch 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 Back
Active ingredientMENTHOL
Label structure7 sections

Dosage and administration

Adults and children 12 years of age and over:Clean and dry affected area. Children under 12 years of age: consult a physician. 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.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Menthol 5%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

  • Temporarily relieves minor aches and pains of muscles and joints due to
  • arthritis
  • simple backache
  • strains
  • sprains
  • bruises.

Warnings:

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • conditions worsen
  • excessive redness or irritation is present
  • 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 12 years of age and over:Clean and dry affected area.

Children under 12 years of age: consult a physician.

  • 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.

Other information:

SPL UNCLASSIFIED SECTION

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

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Glycerin, Sodium polyacrylate, Dihydroxyaluminum Aminoacetate, Methylparaben, Propylparaben, Titanium Dioxide, Kaolin, Polysorbate 80, Propylene Glycol, Tartaric Acid, PVP, Polyacrylic Acid, Water, Petrolatum, CMC, Mineral Oil.

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer Package3Outer Package3Inner Package3Inner Package3Label03Label03

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
69771-012-05GeriGentle FrostyHeat Pain Relief Patch Back0.0308 mL in 1 PACKAGEPATCH0.03083
69771-012-05GeriGentle FrostyHeat Pain Relief Patch Back5 in 1 POUCHPATCH53

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69771-012GERIGENTLE FROSTYHEAT PAIN RELIEF PATCH BACK (MENTHOL) PATCH [GERI-GENTLE CORPORATION]3Current NDC, Legacy NDC, 2 package rows20231111_e442b8ec-a3de-65e8-e053-2995a90af3ec.zip

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69771-01269771-012-05

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
GLYCERINPDC6A3C0OXIACT
DIHYDROXYALUMINUM AMINOACETATEDO250MG0W6IACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
KAOLIN24H4NWX5COIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TARTARIC ACIDW4888I119HIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
WATER059QF0KO0RIACT
PETROLATUM4T6H12BN9UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
MINERAL OILT5L8T28FGPIACT

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 BackMENTHOLGeri-Gentle Corporatione442b8ec-a3de-65e8-e053-2995a90af3ec2023-11-10WarningsExact identifier
ndc (package): 69771-012-05
ndc (product): 69771-012
ndc11 (package): 69771001205
spl id: 09cc827d-1654-bacb-e063-6394a90afbf0
spl set id: e442b8ec-a3de-65e8-e053-2995a90af3ec

Reported adverse events (FAERS/openFDA)#

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