84165-007 Plantar Fasciitis Pain Relief Gel-patch

Drug Facts

Composition & Product

Active Ingredients

Menthol (1 g) Lidocaine (4 g)

Inactive Ingredients

Glycerin Dihydroxyaluminum Aminoacetate Anhydrous Titanium Dioxide Polyacrylic Acid (250000 Mw) Polysorbate 80 Propylene Glycol Kaolin Hydroxyacetophenone Mineral Oil Povidone K90 Water Edetate Disodium Sodium Polyacrylate (2500000 Mw) Tartaric Acid

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2025-05-07

Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.

Dosage and Administration

Adults and Children above 12 years old:

Clean and dry the affected area.

Tear off the protective film and apply the exposedpart of the patch to the affected area.

Carefully remove remaining film while pressingthe patch fimmly on the skin.

Apply 1 patch at a time to affected area, not morethan 3 to 4 times daily.

Remove patch from the skin after at most 8-hourapplication

Children under age of 12:Consult a doctor

Description

LIDOCAINE 4% MENTHOL 1%

Section 50565-1

lf swallowed accidentally , get medical help orcontact with Poison Control Center immediately.

Section 50566-9

localized skin reactions occur, such as rash, itching,redness, irritation, pain, swelling and blistering

econdition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Section 50567-7

use only as directed

avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly

dispose of used patch in manner that always keepsproduct away from children and pets. Used patchesstill contain the drug product that can produce seriousadverse effects if a child or pet chews or ingests this patch.

Section 50570-1

more than 1 patch on your body at a time or withother topical anesthetics at the same time

on wounds or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if you are allergic to any ingredients of this product

Section 51727-6

Dihydroxyaluminum Aminoacetate

Edetate Disodium

Glycerin

Hydroxyacetophenone

Kaolin

Mineral Oil

Polyacrylic Acid

Polysorbate 80

PolyvinylPyrrolidone

Propylene Glycol

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Water

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

LIDOCAINE 4%

MENTHOL 1%

Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.

Dosage and Administration (34068-7)

Adults and Children above 12 years old:

Clean and dry the affected area.

Tear off the protective film and apply the exposedpart of the patch to the affected area.

Carefully remove remaining film while pressingthe patch fimmly on the skin.

Apply 1 patch at a time to affected area, not morethan 3 to 4 times daily.

Remove patch from the skin after at most 8-hourapplication

Children under age of 12:Consult a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

lf swallowed accidentally , get medical help orcontact with Poison Control Center immediately.

Section 50566-9 (50566-9)

localized skin reactions occur, such as rash, itching,redness, irritation, pain, swelling and blistering

econdition worsens

symptoms persist for more than 7 days

symptoms clear up and occur again within a few days

Section 50567-7 (50567-7)

use only as directed

avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly

dispose of used patch in manner that always keepsproduct away from children and pets. Used patchesstill contain the drug product that can produce seriousadverse effects if a child or pet chews or ingests this patch.

Section 50570-1 (50570-1)

more than 1 patch on your body at a time or withother topical anesthetics at the same time

on wounds or damaged skin

with a heating pad or device

with other ointments, creams, sprays, or liniments

if you are allergic to any ingredients of this product

Section 51727-6 (51727-6)

Dihydroxyaluminum Aminoacetate

Edetate Disodium

Glycerin

Hydroxyacetophenone

Kaolin

Mineral Oil

Polyacrylic Acid

Polysorbate 80

PolyvinylPyrrolidone

Propylene Glycol

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical anesthetic

Section 55106-9 (55106-9)

LIDOCAINE 4%

MENTHOL 1%

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34067-9": "Temporarily relieves muscle soreness and minor jointpains in the wrist, knees, back, neck, hips, shoulders,elbows.", "34068-7": "Adults and Children above 12 years old: Clean and dry the affected area. Tear off the protective film and apply the exposedpart of the patch to the affected area. Carefully remove remaining film while pressingthe patch fimmly on the skin. Apply 1 patch at a time to affected area, not morethan 3 to 4 times daily. Remove patch from the skin after at most 8-hourapplication Children under age of 12:Consult a doctor", "34071-1": "For external use only", "50565-1": "lf swallowed accidentally , get medical help orcontact with Poison Control Center immediately.", "50566-9": "localized skin reactions occur, such as rash, itching,redness, irritation, pain, swelling and blistering econdition worsens symptoms persist for more than 7 days symptoms clear up and occur again within a few days", "50567-7": "use only as directed avoid contact with the eyes, mucous membranes, or rashes do not bandage tightly dispose of used patch in manner that always keepsproduct away from children and pets. Used patchesstill contain the drug product that can produce seriousadverse effects if a child or pet chews or ingests this patch.", "50570-1": "more than 1 patch on your body at a time or withother topical anesthetics at the same time on wounds or damaged skin with a heating pad or device with other ointments, creams, sprays, or liniments if you are allergic to any ingredients of this product", "51727-6": "Dihydroxyaluminum Aminoacetate Edetate Disodium Glycerin Hydroxyacetophenone Kaolin Mineral Oil Polyacrylic Acid Polysorbate 80 PolyvinylPyrrolidone Propylene Glycol Sodium Polyacrylate Tartaric Acid Titanium Dioxide Water", "55105-1": "Topical anesthetic", "55106-9": "LIDOCAINE 4% MENTHOL 1%"}