Pain Relief Patch 4% Lidocaine

Pain Relief Patch 4% Lidocaine
SPL v2
SPL
SPL Set ID 41c26a66-3371-2c2c-e063-6294a90aa38b
Route
TOPICAL
Published
Effective Date 2025-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Povidone, Unspecified Dihydroxyaluminum Aminoacetate Polyacrylic Acid (8000 Mw) Polysorbate 80 Kaolin Glycerin Ethylhexylglycerin Propylene Glycol Phenoxyethanol Tartaric Acid Titanium Dioxide Water Iodopropynyl Butylcarbamate Carboxymethylcellulose Sodium, Unspecified Form Petrolatum

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2025-11-01

Description

Lidocaine 4%

Purpose

External analgesic


Medication Information

Purpose

External analgesic

Description

Lidocaine 4%

Uses

For temporary relief of pain

Label

Warnings

For external use only

Directions

■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 8 hour period. Maximum 3 patches per day. Discard patch after single use.

■Children under 2 years of age: Do not use, ask a doctor

Do Not Use

over raw surfeces or blistered areas

Active Ingredient

Lidocaine 4%

Other Information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. 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.

Inactive Ingredients

aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions Or Comments?

Toll free 866-326-1313

When Using This Product

■ avoid contact with the eyes

■ do not use more than one patch on your body at a time

Stop Use and Ask A Doctor If

skin irritation develops

conditions worsen

symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children and Pets.

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.


Structured Label Content

Uses

For temporary relief of pain

Label

Purpose

External analgesic

Warnings

For external use only

Directions

■ Adults and children 2 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 8 hour period. Maximum 3 patches per day. Discard patch after single use.

■Children under 2 years of age: Do not use, ask a doctor

Do Not Use (Do not use)

over raw surfeces or blistered areas

Active Ingredient

Lidocaine 4%

Other Information (Other information)

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture. 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.

Inactive Ingredients

aluminum glycinate, carboxymethylcellulose sodium, glycerin, iodopropynyl butylcarbamate, kaolin, petrolatum, phenoxyethanol, polyacrylic acid, polysorbate 80, povidone, propylene glycol, sodium polyacrylate, tartaric acid, titanium dioxide, water, 3-(2-ethylhexyloxy)propane-1,2-diol

Questions Or Comments? (Questions or comments?)

Toll free 866-326-1313

When Using This Product (When using this product)

■ avoid contact with the eyes

■ do not use more than one patch on your body at a time

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

skin irritation develops

conditions worsen

symptoms persist for more than 7 days or clear up and occur again within a few days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children and Pets. (Keep out of reach of children and pets.)

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.


Advanced Ingredient Data


Raw Label Data

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