Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 21208a66-b293-4429-8c87-4bca2290df4f
Route
TOPICAL
Published
Effective Date 2020-07-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (240 mg)
Inactive Ingredients
Glycerin Propylene Glycol Sorbitol Urea Carboxymethylcellulose Sodium, Unspecified Gelatin Kaolin Polyvinyl Alcohol, Unspecified Titanium Dioxide Tartaric Acid Methylparaben Dihydroxyaluminum Aminoacetate Edetate Disodium Polysorbate 80 Propylparaben Sorbitan Monooleate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2020-07-01

Description

Lidocaine 4%

Purpose

Topical Anesthetic


Medication Information

Purpose

Topical Anesthetic

Description

Lidocaine 4%

Uses

For temporary relief of minor pain

Warnings

For external use only

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Do not use

■ More than 1 patch on your body at a time ■ On the cut, irritated, swollen or puncture wounds ■ For more than one week without consulting a doctor

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Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients

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When using this product

■ Use only as directed ■ Read and follow all directions and warnings on this label ■ 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 ■ Make sure to dispose the used patch away from children and pets, as used ones still contain the drug that can cause serious adverse effects on them if they chew or ingest the patch

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Stop use and ask a doctor if

■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury such as pain, swelling or blistering where the product was applied

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

Directions

Adult and children 12 years of age and over :

■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch for up to 12 hours

Children under 12 years of age : Consult a physician

Other Information

■ Store at room temperature 68° to 77°F (20° to 25°C) ■ Store in a clean, dry place out of direct sunlight ■ Protect from excessive moisture

Active Ingredients

Lidocaine 4%

Inactive Ingredients

Glycerin, Propylene Glycol, D-Sorbitol Solution, Sodium Polyacrylate, Polyacrylic Acid, Urea, Gelatin, Carboxymethylcellulose Sodium, Kaolin, Castor Oil, Polyvinyl Alcohol, Titanium Oxide, Tartaric Acid, Methylparaben, Dihydroxyaluminum Aminoacetate, Disodium Edetate Hydrate, Polysorbate 80, Propylparaben, Sorbitan Oleate, Water

Questions Or Comments

■ Visit us at : icure.co.kr/en ■ Contact us : [email protected]

Package Label.principal Display Panel

Keep Out of Reach of Children and Pets

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


Structured Label Content

Uses

For temporary relief of minor pain

Purpose (PURPOSE)

Topical Anesthetic

Warnings (WARNINGS)

For external use only

--------------------------------------------------------------------------------------------------------

Do not use

■ More than 1 patch on your body at a time ■ On the cut, irritated, swollen or puncture wounds ■ For more than one week without consulting a doctor

--------------------------------------------------------------------------------------------------------

Ask a doctor or pharmacist before use if you are allergic to any active or inactive ingredients

--------------------------------------------------------------------------------------------------------

When using this product

■ Use only as directed ■ Read and follow all directions and warnings on this label ■ 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 ■ Make sure to dispose the used patch away from children and pets, as used ones still contain the drug that can cause serious adverse effects on them if they chew or ingest the patch

--------------------------------------------------------------------------------------------------------

Stop use and ask a doctor if

■ Condition worsens ■ Redness is present ■ Irritation develops ■ Symptoms persist for more than 7 days or clear up and occur again within a few days ■ You experience signs of skin injury such as pain, swelling or blistering where the product was applied

--------------------------------------------------------------------------------------------------------

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

Directions

Adult and children 12 years of age and over :

■ Clean and dry affected area ■ Peel film from patch and apply to the skin (see illustration) ■ Use 1 patch for up to 12 hours

Children under 12 years of age : Consult a physician

Other Information

■ Store at room temperature 68° to 77°F (20° to 25°C) ■ Store in a clean, dry place out of direct sunlight ■ Protect from excessive moisture

Active Ingredients (ACTIVE INGREDIENTS)

Lidocaine 4%

Inactive Ingredients (INACTIVE INGREDIENTS)

Glycerin, Propylene Glycol, D-Sorbitol Solution, Sodium Polyacrylate, Polyacrylic Acid, Urea, Gelatin, Carboxymethylcellulose Sodium, Kaolin, Castor Oil, Polyvinyl Alcohol, Titanium Oxide, Tartaric Acid, Methylparaben, Dihydroxyaluminum Aminoacetate, Disodium Edetate Hydrate, Polysorbate 80, Propylparaben, Sorbitan Oleate, Water

Questions Or Comments (Questions or Comments)

■ Visit us at : icure.co.kr/en ■ Contact us : [email protected]

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

Keep Out of Reach of Children and Pets (Keep out of reach of children and pets)

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


Advanced Ingredient Data


Raw Label Data

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