Lidocaine Pain Relief Gel-Patch (19) DailyMed Label

Key Label Information

Active Ingredients And Purpose

Active ingredient

Lidocaine 4%

Purpose

Topical Anesthetic

Uses

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

Usage

1. Remove patch from outer package 2. Partially peel back protection film 3. Place on affected area 4. Remove remaining film while pressing patch to skin

Warnings

For external use only

Do not use

■ on wounds or damaged skin ■ with a heating pad or device ■ with other ointments, creams, sprays, or liniments ■ if you are allergic to any ingredients of this product

... ask a doctor if

■ skin reactions such as redness, swelling, blistering or other discomfort occur ■ symptoms persist for more than 7 days

If pregnant or breast-feeding

ask a health professional before use.

Directions And Dosage

Directions

Adults and Children above 12 years old : ■ Clean and dry the affected area. ■ Tear off the proctive film and apply the exposed part of the patch to the affected area. ■ Carefully remove remaining film while pressing the patch firmly on the skin. ■ Remove patch from the skin after at most 8-hour application. Children under age of 12 : Consult a doctor

Other Label Information

Inactive ingredients

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Questions or Comments

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517-13

Products

Lidocaine Pain Relief Gel-Patch

NDC Codes

Ingredients

Name	UNII	Kind
EDETATE DISODIUM	7FLD91C86K	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
GLYCERIN	PDC6A3C0OX	IACT
POVIDONE K90	RDH86HJV5Z	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
KAOLIN	24H4NWX5CO	IACT
TARTARIC ACID	W4888I119H	IACT
WATER	059QF0KO0R	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	IACT
SODIUM POLYACRYLATE (2500000 MW)	05I15JNI2J	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS	1K713C615K	IACT
LIDOCAINE	98PI200987	ACTIB

Complete SPL Sections

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical Anesthetic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves muscle soreness and minor joint pains in the wrist, knees, back, neck, hips, shoulders, elbows.

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

■ on wounds or damaged skin ■ with a heating pad or device ■ with other ointments, creams, sprays, or liniments ■ if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

■ use only as directed ■ avoid contact with the eyes, mucous membranes, or rashes ■ do not bandage tightly

Stop use ... if

OTC - STOP USE SECTION

■ skin reactions such as redness, swelling, blistering or other discomfort occur ■ symptoms persist for more than 7 days

... ask a doctor if

OTC - ASK DOCTOR SECTION

■ skin reactions such as redness, swelling, blistering or other discomfort occur ■ symptoms persist for more than 7 days

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed accidentally, get medical help or contact with Poison Control Center immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and Children above 12 years old : ■ Clean and dry the affected area. ■ Tear off the proctive film and apply the exposed part of the patch to the affected area. ■ Carefully remove remaining film while pressing the patch firmly on the skin. ■ Remove patch from the skin after at most 8-hour application. Children under age of 12 : Consult a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate, Disodium Ethylenediaminetetraacetic Acid, Glycerin, Kaolin, Methylparaben, Polysorbate 80, Propylene Glycol, Polyacrylic Acid, Polyvinylpyrrolidone K90, Propylparaben, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water

Usage

INDICATIONS & USAGE SECTION

1. Remove patch from outer package 2. Partially peel back protection film 3. Place on affected area 4. Remove remaining film while pressing patch to skin