Lidocaine Patch

Lidocaine Patch
SPL v3
SPL
SPL Set ID 054d357c-6a37-5e39-e063-6394a90a5b74
Route
TOPICAL
Published
Effective Date 2023-09-14
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Menthol (0.01 g) Lidocaine (0.04 g)
Inactive Ingredients
Polyacrylic Acid (250000 Mw) Sodium Polyacrylate (2500000 Mw) Urea Tartaric Acid Water Titanium Dioxide Dihydroxyaluminum Aminoacetate Anhydrous Carboxymethylcellulose Silicon Dioxide Aluminum Hydroxide Propylene Glycol Methylparaben Polysorbate 80 Castor Oil Glycerin Polyoxyl 40 Hydrogenated Castor Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-09-14

Description

Lidocaine Patch


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For the temporary relief of palin, TOPICAL ANESTHETIC

Dosage and Administration

Adults and children 12 years of age and over:

clean and dry aftecied area

remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

carefully remave smaller portion of backing from patch and apply exposed portion of patch to atlected area

once exposed portion of patch is positioned, carefully remove remaining backing to completely applypatch to aitected area

use 2 patch tor up to 24 hours

Children under 12 years of age:consult a doctor

Description

Lidocaine Patch

Section 42229-5

Lidocaine Patch

Section 44425-7

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

Section 50565-1

it swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9

condition worsens

rodness is present

irritation develops

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

you experience sians ot skin injury, such as pain, swelling, or blistering where the product was applied

Section 50567-7

use only as directod. Read and follow all directions and warnings on this label.

rare cases of serious bums have been reported with products of this type

do not apply to wounds or damaged, broken or irritated skin

do not allow contact with the eyes and mucous membranes

do not bandage tightly or apply local heat (such as heating pads) to the area of use

do not use at the same time as other topical analgesics

Section 50570-1

more than 1 patch on your body at a time or on cut, irritated or swollen skin

Section 51727-6

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

Glycerin

Methylparaben

PEG-40 Hydrogenated Castor Oil

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis Seed Oil (Castor)

Silica

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

Water

Section 51945-4

Section 55105-1

For the temporary relief of palin

Section 55106-9

Lidocaine 4%,Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of palin, TOPICAL ANESTHETIC

Dosage and Administration (34068-7)

Adults and children 12 years of age and over:

clean and dry aftecied area

remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle

carefully remave smaller portion of backing from patch and apply exposed portion of patch to atlected area

once exposed portion of patch is positioned, carefully remove remaining backing to completely applypatch to aitected area

use 2 patch tor up to 24 hours

Children under 12 years of age:consult a doctor

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Lidocaine Patch

Section 44425-7 (44425-7)

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

Section 50565-1 (50565-1)

it swallowed, get medical help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

condition worsens

rodness is present

irritation develops

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

you experience sians ot skin injury, such as pain, swelling, or blistering where the product was applied

Section 50567-7 (50567-7)

use only as directod. Read and follow all directions and warnings on this label.

rare cases of serious bums have been reported with products of this type

do not apply to wounds or damaged, broken or irritated skin

do not allow contact with the eyes and mucous membranes

do not bandage tightly or apply local heat (such as heating pads) to the area of use

do not use at the same time as other topical analgesics

Section 50570-1 (50570-1)

more than 1 patch on your body at a time or on cut, irritated or swollen skin

Section 51727-6 (51727-6)

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

Glycerin

Methylparaben

PEG-40 Hydrogenated Castor Oil

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis Seed Oil (Castor)

Silica

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

Water

Section 51945-4 (51945-4)

Section 55105-1 (55105-1)

For the temporary relief of palin

Section 55106-9 (55106-9)

Lidocaine 4%,Menthol 1%


Advanced Ingredient Data


Raw Label Data

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