87278-003 4% Lidocaine Pain Relief Patch

87278-003 4% Lidocaine Pain Relief Patch
SPL v1
SPL
SPL Set ID 4981e9c3-2a19-aed8-e063-6294a90af216
Route
TRANSDERMAL
Published
Effective Date 2026-01-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (0.04 g)
Inactive Ingredients
Polysorbate 80 Water Edetate Disodium Kaolin Dihydroxyaluminum Aminoacetate Anhydrous Carbomer Tartaric Acid Povidone K90 Glycerin Propylene Glycol Sodium Polyacrylate (2500000 Mw) Dmdm Hydantoin Carboxymethylcellulose Sodium

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2026-01-29

Description

Lidocaine 4%


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

For temporary relief of pain

Dosage and Administration



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

Description

Lidocaine 4%

Section 50565-1



If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. lf 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

condition worsen

symptoms persist 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 rashes

do not bandage tightly

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

Dihydroxyaluminum aminoacetate anhydrous

Edetate disodium

Tartaric acid

Povidone K90

DMDM Hydantoin

Polysorbate 80

Propylene glycol

Carboxymethylcellulose sodium

Kaolin

Carbomer

Sodium polyacrylate

Water

Section 51945-4

Section 55105-1

Topical anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

For temporary relief of pain

Dosage and Administration (34068-7)



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

Warnings and Precautions (34071-1)

For external use only

Section 50565-1 (50565-1)



If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. lf 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

condition worsen

symptoms persist 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 rashes

do not bandage tightly

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

Dihydroxyaluminum aminoacetate anhydrous

Edetate disodium

Tartaric acid

Povidone K90

DMDM Hydantoin

Polysorbate 80

Propylene glycol

Carboxymethylcellulose sodium

Kaolin

Carbomer

Sodium polyacrylate

Water

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

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