Lidocaine Patch

Lidocaine Patch
SPL v1
SPL
SPL Set ID 16ab732a-b497-c2e0-e063-6394a90aeb8c
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) Menthol (1 g)
Inactive Ingredients
Castor Oil Tartaric Acid Polyacrylic Acid (250000 Mw) Urea Water Silicon Dioxide Sodium Polyacrylate (2500000 Mw) Dihydroxyaluminum Aminoacetate Anhydrous Polyoxyl 40 Hydrogenated Castor Oil Titanium Dioxide Aluminum Hydroxide Dmdm Hydantoin Carboxymethylcellulose Glycerin Polysorbate 80 Propylene Glycol

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 minor aches and pains of muscles and joints

Dosage and Administration

Adults and children 2 years of age and older

clean and dry affected area

remove backing trom patch and firmly grasp both ends, gently pull backing until it separates up to the middle

slowly apply the patch to the affected area and gently remove any remaining backing from the patch

apply to affected area not more than 3 to 4 times daily

Description

Lidocaine Patch

Section 42229-5

Lidocaine Patch

Section 44425-7

Store in a clean, and dry place outside of direct sunlight.

Section 50565-1

Keep out of reach of children

Section 50566-9

if condition worsens

if symptoms clear up and occur again within a few days

if redness and irritation develop

if symptoms persist for more than 7 days, consult a doctor

Section 50567-7

use only as directed

avoid contact with eyes

do not apply to wounds or damaged skin

do not bandage tightly or apply any other heating pads to the affected area

Section 50570-1

use only as directed

avoid contact with eyes

do not apply to wounds or damaged skin

do not bandage tightly or apply any other heating pads to the affected area

Section 51727-6

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

DMDM hydantoin

Glycerin

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

Topical Anesthetic

Section 55106-9

Lidocaine 4%

Menthol 1%


Structured Label Content

Indications and Usage (34067-9)

For the temporary relief of minor aches and pains of muscles and joints

Dosage and Administration (34068-7)

Adults and children 2 years of age and older

clean and dry affected area

remove backing trom patch and firmly grasp both ends, gently pull backing until it separates up to the middle

slowly apply the patch to the affected area and gently remove any remaining backing from the patch

apply to affected area not more than 3 to 4 times daily

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, and dry place outside of direct sunlight.

Section 50565-1 (50565-1)

Keep out of reach of children

Section 50566-9 (50566-9)

if condition worsens

if symptoms clear up and occur again within a few days

if redness and irritation develop

if symptoms persist for more than 7 days, consult a doctor

Section 50567-7 (50567-7)

use only as directed

avoid contact with eyes

do not apply to wounds or damaged skin

do not bandage tightly or apply any other heating pads to the affected area

Section 50570-1 (50570-1)

use only as directed

avoid contact with eyes

do not apply to wounds or damaged skin

do not bandage tightly or apply any other heating pads to the affected area

Section 51727-6 (51727-6)

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

DMDM hydantoin

Glycerin

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)

Topical Anesthetic

Section 55106-9 (55106-9)

Lidocaine 4%

Menthol 1%


Advanced Ingredient Data


Raw Label Data

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