Lidocaine Pain Relief Gel-patch

Lidocaine Pain Relief Gel-patch
SPL v2
SPL
SPL Set ID 3304e362-dcda-3f5e-e063-6294a90a7015
Route
TOPICAL
Published
Effective Date 2025-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-04-18

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves muscle soreness and minor jointpains in the wrist, knces, back, neck, hips, shouldcrs,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 of the patch to the affected area.

· Carefully remove remaining film while pressing the patch firmly on the skin.

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

· Remove patch from the skin after at most 8-hour application

Children under age of 12:Consult a doctor

Description

Lidocaine 4%

Section 50565-1

ask a health professional before use.

Section 50566-9

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

· condition 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 keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse 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 with other 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 Anhydrous

Glycerin

Kaolin

Methylparaben

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Propylparaben

PVP

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Water

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves muscle soreness and minor jointpains in the wrist, knces, back, neck, hips, shouldcrs,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 of the patch to the affected area.

· Carefully remove remaining film while pressing the patch firmly on the skin.

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

· Remove patch from the skin after at most 8-hour application

Children under age of 12:Consult a doctor

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)

ask a health professional before use.

Section 50566-9 (50566-9)

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

· condition 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 keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse 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 with other 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 Anhydrous

Glycerin

Kaolin

Methylparaben

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Propylparaben

PVP

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%


Advanced Ingredient Data


Raw Label Data

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