SPL v5
SPL
SPL Set ID 63911880-8194-4c7d-a72f-cab94761b2d7
Routes
TOPICAL PERCUTANEOUS TRANSDERMAL
Published
Effective Date 2025-12-23
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (560 mg)
Inactive Ingredients
Aluminum Silicate Dihydroxyaluminum Aminoacetate Edetate Disodium Gelatin Glycerin Methylparaben Oleic Acid Propylene Glycol Propylparaben Tartaric Acid Titanium Dioxide Water

Identifiers & Packaging

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

Description

Lidocaine 4%

Purpose

Topical anesthetic


Medication Information

Purpose

Topical anesthetic

Description

Lidocaine 4%

Uses

For temporary relief of pain

Warnings

For external use only

Directions

Adults 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

Do Not Use

● 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

Active Ingredient

Lidocaine 4%

Other Information

● Avoid storing product in direct sunlight

● Protect product from excessive moisture

Inactive Ingredients

aluminum silicate, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxyde, water

Questions Or Comments?

Toll free 1-800-826-8861   www.salonpas.us

Principal Display Panel

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#55328-100-02

Desensitize aggravated nerves

for temprary relief of pain

● Back

● Neck

● Shoulders

● Knees & Elbows

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

● Numbing Relief

● Unscented

2 PATCHES

3 15/16'' X 5 1/2'' (10cm X 14cm)

When Using This Product

● use only as directed

● avoid contact with the eyes, mucous membranes or rashes

● do not bandage tightly

Stop Use and Ask A Doctor If

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

● conditions worsen

● symptoms persist for more than 7 days

● symptoms clear up and occur again within a few days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

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


Structured Label Content

Uses

For temporary relief of pain

Purpose

Topical anesthetic

Warnings

For external use only

Directions

Adults 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

Do Not Use (Do not use)

● 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

Active Ingredient (Active ingredient)

Lidocaine 4%

Other Information (Other information)

● Avoid storing product in direct sunlight

● Protect product from excessive moisture

Inactive Ingredients (Inactive ingredients)

aluminum silicate, dihydroxyaluminum aminoacetate, disodium edetate, gelatin, glycerin, methylparaben, oleic acid, polyacrylic acid, polyvinyl alcohol, propylene glycol, propylparaben, sodium polyacrylate, tartaric acid, titanium dioxyde, water

Questions Or Comments? (Questions or comments?)

Toll free 1-800-826-8861   www.salonpas.us

Principal Display Panel

OTC topical analgesics in patch category*

WORLD'S BRAND NO.1

Hisamitsu

NDC#55328-100-02

Desensitize aggravated nerves

for temprary relief of pain

● Back

● Neck

● Shoulders

● Knees & Elbows

Salonpas LIDOCAINE 4% Pain Relieving Gel-Patch

APPLY FOR UP TO 8 HOURS

MAXIMUM OTC STRENGTH

● Numbing Relief

● Unscented

2 PATCHES

3 15/16'' X 5 1/2'' (10cm X 14cm)

When Using This Product (When using this product)

● use only as directed

● avoid contact with the eyes, mucous membranes or rashes

● do not bandage tightly

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

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

● conditions worsen

● symptoms persist for more than 7 days

● symptoms clear up and occur again within a few days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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