41cb1135-84e0-0c9a-e063-6294a90ada96

SPL v1
SPL
SPL Set ID 41cb1135-84e0-0c9a-e063-6294a90ada96
Route
topical
Published
Effective Date 2025-10-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
lidocaine (0.04 g)
Inactive Ingredients
methylparaben titanium dioxide propylene glycol tartaric acid sodium polyacrylate (2500000 mw) water dihydroxyaluminum aminoacetate anhydrous polysorbate 80 glycerin polyacrylic acid (250000 mw) kaolin edetate disodium propylparaben povidone k90

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
otc monograph drug active Since 2025-10-23

Description

Lidocaine 4% ...... Purpose: Topical Anesthetic


Medication Information

Warnings and Precautions

For external use only

Active Ingredient

Lidocaine 4% ...... Purpose: Topical Anesthetic

Indications and Usage

Adult and Children 12 years of age and over:

Clean and dry affected area

Remove film from patch and apply to the skin (see illustration)

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 12 years of age: Consult a doctor

Dosage and Administration

This is a strip, patch dosage form.

The active ingredient strength is 4% w/w.

One patch one time, no more than 8 hours one time.

Description

Lidocaine 4% ...... Purpose: Topical Anesthetic

Section 43684-0

For temporary relief of pain

Section 50565-1

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9

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

Conditions worsen

Symptoms persists 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 rashed

Do not bandage tightly

Section 50568-5

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

Conditions worsen

Symptoms persists for more than 7 days

Symptoms clear up and occur again within a few days

Section 50570-1

More than 1 patch at a time

On wounds or damaged skin

With a heating pad

If you are allergic to any ingredients of this product

Section 51727-6

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water

Section 51945-4

Section 53413-1
Section 53414-9

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1

Topical Anesthetic

Section 60561-8

Avoid storing product in direct sunlight

Protect product from excessive moisture


Structured Label Content

Warnings and Precautions (34071-1)

For external use only

Active Ingredient (55106-9)

Lidocaine 4% ...... Purpose: Topical Anesthetic

Indications and Usage (34067-9)

Adult and Children 12 years of age and over:

Clean and dry affected area

Remove film from patch and apply to the skin (see illustration)

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 12 years of age: Consult a doctor

Dosage and Administration (34068-7)

This is a strip, patch dosage form.

The active ingredient strength is 4% w/w.

One patch one time, no more than 8 hours one time.

Section 43684-0 (43684-0)

For temporary relief of pain

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

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

Conditions worsen

Symptoms persists 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 rashed

Do not bandage tightly

Section 50568-5 (50568-5)

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

Conditions worsen

Symptoms persists for more than 7 days

Symptoms clear up and occur again within a few days

Section 50570-1 (50570-1)

More than 1 patch at a time

On wounds or damaged skin

With a heating pad

If you are allergic to any ingredients of this product

Section 51727-6 (51727-6)

Glycerin, Sodium Polyacrylate, Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Kaolin, Titanium Dioxide, Polysorbate 80, Propylene Glycol, Tartaric Acid, Polyacrylic Acid, Polyvinylpyrrolidone K90, Methylparaben, Propylparaben, Water

Section 51945-4 (51945-4)

Section 53413-1 (53413-1)
Section 53414-9 (53414-9)

If pregnant or breastfeeding, ask a health professional before use

Section 55105-1 (55105-1)

Topical Anesthetic

Section 60561-8 (60561-8)

Avoid storing product in direct sunlight

Protect product from excessive moisture


Advanced Ingredient Data


Raw Label Data

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