84165-103 Lidocaine Pain Relieving Gel-patch

84165-103 Lidocaine Pain Relieving Gel-patch
SPL v3
SPL
SPL Set ID 2159fb73-cf6c-184a-e063-6394a90a1d14
Route
TOPICAL
Published
Effective Date 2024-09-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-09-05

Description

LIDOCAINE PAIN RELIEVING GEL-PATCH


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarly 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 fimly on the skin.

Remove patch from the skin after at most 8-hourapplication

Children under age of 12:Consult a doctor

Description

LIDOCAINE PAIN RELIEVING GEL-PATCH

Section 42229-5

LIDOCAINE PAIN RELIEVING GEL-PATCH

Section 50565-1

Ifswallowed accidentally , get medical help orcontact 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 Anhydrous

Edetate Disodium

Glycerin

Kaolin

Methylparaben

Polyacrylic Acid

Polysorbate 80

PolyvinylPyrrolidone K90

Propylene Glycol

Propylparaben

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Water

Section 51945-4

Section 55105-1

Topical Analgesic

Section 55106-9

LIDOCAINE 4%


Structured Label Content

Indications and Usage (34067-9)

Temporarly 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 fimly 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)

LIDOCAINE PAIN RELIEVING GEL-PATCH

Section 50565-1 (50565-1)

Ifswallowed accidentally , get medical help orcontact 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 Anhydrous

Edetate Disodium

Glycerin

Kaolin

Methylparaben

Polyacrylic Acid

Polysorbate 80

PolyvinylPyrrolidone K90

Propylene Glycol

Propylparaben

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

Topical Analgesic

Section 55106-9 (55106-9)

LIDOCAINE 4%


Advanced Ingredient Data


Raw Label Data

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