SPL v3
SPL
SPL Set ID 16aa3bcc-81f7-6532-e063-6394a90ace29
Route
TOPICAL
Published
Effective Date 2024-04-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Tartaric Acid Propylene Glycol Polyvinyl Alcohol (18000 Mw) Alcohol Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Glycerin Methyl Acrylate Dihydroxyaluminum Aminoacetate Anhydrous Polysorbate 80 Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-04-22

Description

LIDOCAINE PATCH


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the temporary relief of pain

Dosage and Administration

Adults and children 12 years of age and older:

Wash and dry the affected area.

Peel off the backing film from one side of the patch carefully

Apply the exposed portion of the patch to the affected area.

Gently press the patch with your hand to fit the affected area completely.

Do not exercise vigorously during use to prevent the patch from falling off.

Use only 1 patch for a maximum of 8 hours.

Children under 12 years of age: Ask a doctor before use

Description

LIDOCAINE PATCH

Section 42229-5

LIDOCAINE PATCH

Section 44425-7

store at room temperature 15°-30C (59-86F).

Section 50565-1

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

Section 50566-9

condition worsens

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

redness or irritation develops

you experience signs of skin injury, such as pain, sweling, or blistering where

the product was applied

Section 50567-7

use only as directed. Read and follow all directions and warnings on this carton.

do not allow contact with the eyes

heat (such as heating pads) to the area of use

do not use at the same time as other topical analgesics

dispose of used patch in manner that always keeps product away from children and pets.

Used patches stll 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

on cut,irritated,or swollen skin

on puncture wounds

for more than one week without consulting a doctor

Section 51727-6

aluminum glycinate

glycerin

methyl acrylate

polyacrylic acid

polysorbate 80

propylene glycol

sodium polyacrylate

tartaric acid

poval

alcohol

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of pain

Dosage and Administration (34068-7)

Adults and children 12 years of age and older:

Wash and dry the affected area.

Peel off the backing film from one side of the patch carefully

Apply the exposed portion of the patch to the affected area.

Gently press the patch with your hand to fit the affected area completely.

Do not exercise vigorously during use to prevent the patch from falling off.

Use only 1 patch for a maximum of 8 hours.

Children under 12 years of age: Ask a doctor before use

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

LIDOCAINE PATCH

Section 44425-7 (44425-7)

store at room temperature 15°-30C (59-86F).

Section 50565-1 (50565-1)

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

Section 50566-9 (50566-9)

condition worsens

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

redness or irritation develops

you experience signs of skin injury, such as pain, sweling, or blistering where

the product was applied

Section 50567-7 (50567-7)

use only as directed. Read and follow all directions and warnings on this carton.

do not allow contact with the eyes

heat (such as heating pads) to the area of use

do not use at the same time as other topical analgesics

dispose of used patch in manner that always keeps product away from children and pets.

Used patches stll 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

on cut,irritated,or swollen skin

on puncture wounds

for more than one week without consulting a doctor

Section 51727-6 (51727-6)

aluminum glycinate

glycerin

methyl acrylate

polyacrylic acid

polysorbate 80

propylene glycol

sodium polyacrylate

tartaric acid

poval

alcohol

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

All Sections (JSON)