84165-104 Pain Relief Gel-patch

84165-104 Pain Relief Gel-patch
SPL v2
SPL
SPL Set ID 22d9ce20-1cb6-c5bd-e063-6394a90a9eca
Route
TOPICAL
Published
Effective Date 2024-09-24
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.01 g) Lidocaine (0.04 g)
Inactive Ingredients
Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous Edetate Disodium Propylene Glycol Polysorbate 80 Glycerin Kaolin Povidone K90 Mineral Oil Polyacrylic Acid (250000 Mw) Water Tartaric Acid Sodium Polyacrylate (2500000 Mw) Hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-24

Description

PAIN RELIEF Gel-Patch


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves muscle soreness and minor joint pains

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 exposed part ofthe patch to the the affected area.

Carefully remove remaining film while pressing the patchfirmly on the skin.

Remove patch from the skin after at most 8-hourapplication.

Children under age of 12: Consult a doctor

Description

PAIN RELIEF Gel-Patch

Section 42229-5

PAIN RELIEF Gel-Patch

Section 50565-1

lf swallowed accidentally, get medical help or contact

with Poison Control Center immediately

Section 50566-9

skin reactions such as redness, swelling, blistering or other discomfort occur

symptoms persist for more than 7 days

Section 50567-7

use only as directed

avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly

Section 50570-1

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 joint pains

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 exposed part ofthe patch to the the affected area.

Carefully remove remaining film while pressing the patchfirmly on the skin.

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 42229-5 (42229-5)

PAIN RELIEF Gel-Patch

Section 50565-1 (50565-1)

lf swallowed accidentally, get medical help or contact

with Poison Control Center immediately

Section 50566-9 (50566-9)

skin reactions such as redness, swelling, blistering or other discomfort occur

symptoms persist for more than 7 days

Section 50567-7 (50567-7)

use only as directed

avoid contact with the eyes, mucous membranes, or rashes

do not bandage tightly

Section 50570-1 (50570-1)

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


Raw Label Data

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