69561-005-01

69561-005-01
SPL v3
SPL
SPL Set ID 1e31b950-e990-e255-e063-6394a90a7d23
Route
TOPICAL
Published
Effective Date 2024-07-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Sodium Polyacrylate (2500000 Mw) Polyacrylic Acid (250000 Mw) Glycerin Tartaric Acid Povidone K90 Water Kaolin Edetate Disodium Propylene Glycol Mineral Oil Polysorbate 80 Titanium Dioxide Dihydroxyaluminum Aminoacetate Hydroxyacetophenone

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-07-27

Description

LIDOCAINE 4%

Purpose

Topical Analgesic


Medication Information

Purpose

Topical Analgesic

Description

LIDOCAINE 4%

Use

For temporary relief of pain

Stop Use

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

■ condition worsen

■ symptoms persist far more than 7 days

■ symptoms clear up and occur again within a few days

Warnings

For external use only

Questions
Ask Doctor

lf pregnant or breast-feeding

Directions

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

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

When Using

■ use only as directed

■ avoid contact with the eyes, mucous membranes, or rashes

■ do not bandage tightly

Active Ingredient

LIDOCAINE 4%

Other Information

■ Avoid storing product in direct sunlight

■ Protect product from excessive moisture

Inactive Ingredients

Dihydroxyaluminum Aminoacetate,Edetate Disodium,Glycerin,Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral oil.Polysorbate 80, Polyacrylic Acid,Polyvinylpyrrolidone K90,Propylene Glycol, Sodium Polyacrylate,Titanium Dioxide,Water.

Principal Display Panel

Keep Out of Reach of Children

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


Structured Label Content

Use

For temporary relief of pain

Purpose

Topical Analgesic

Stop Use

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

■ condition worsen

■ symptoms persist far more than 7 days

■ symptoms clear up and occur again within a few days

Warnings

For external use only

Questions
Ask Doctor

lf pregnant or breast-feeding

Directions

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

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

When Using

■ use only as directed

■ avoid contact with the eyes, mucous membranes, or rashes

■ do not bandage tightly

Active Ingredient

LIDOCAINE 4%

Other Information (Other information)

■ Avoid storing product in direct sunlight

■ Protect product from excessive moisture

Inactive Ingredients (Inactive ingredients)

Dihydroxyaluminum Aminoacetate,Edetate Disodium,Glycerin,Hydroxyacetophenone, Kaolin, L(+)-Tartaric Acid, Mineral oil.Polysorbate 80, Polyacrylic Acid,Polyvinylpyrrolidone K90,Propylene Glycol, Sodium Polyacrylate,Titanium Dioxide,Water.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children (Keep Out Of Reach Of Children)

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


Advanced Ingredient Data


Raw Label Data

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