Lidocaine Patch

Lidocaine Patch
SPL v2
SPL
SPL Set ID 13eab4ea-6a78-a393-e063-6294a90a5995
Route
TOPICAL
Published
Effective Date 2024-03-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g)
Inactive Ingredients
Silicon Dioxide Aluminum Hydroxide Polyacrylic Acid (250000 Mw) Castor Oil Dmdm Hydantoin Glycerin Propylene Glycol Titanium Dioxide Polysorbate 80 Water Sodium Polyacrylate (8000 Mw) Tartaric Acid Urea Dihydroxyaluminum Aminoacetate Anhydrous Carboxymethylcellulose Sodium, Unspecified Form

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-03-18

Description

Lidocaine Patch


Medication Information

Warnings and Precautions

For external use only

Indications and Usage

Temporarily relieves minor pain.

Dosage and Administration

Adults and children 12 years of age and over: Clean and dry affected area.Carefully remove backing from patchstarting at a corner. Apply sticky side of patchto affected area. Use one patch for up to 12 hours. Discard patch aftersingleuse.Children under 12 years of age: consult a physician.

Description

Lidocaine Patch

Section 42229-5

Lidocaine Patch

Section 44425-7

Store in a clean, dry place outside of direct sunlight. Protect product form

excessive moisture.

Section 50565-1

Keep out of reach of children and pets

Section 50566-9

Stop use and consult 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.

Section 50567-7

When using this product Use only as directed Read and follow alldirections and warings on this carton Do not allow contact with the eyes

Do not use at the same time as other topical analgesics

Do not bandage tightly orapply local heat (such as heating pads) to the area of use

Dispose of usedpatch inmanner that always keeps product away from children and pets, Used patches stil contain the drug product that can produce serious adverse effects ifa child or pet chews or ingests this patch.

Section 50570-1

More than one patch on your body at a time

On cut, initated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

lf you are allergic to any active or inactive ingredients lf pouch is damaged or opened.

Section 51727-6

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

DMDM hydantoin

Glycerin

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis Seed Oil (castor)

Silica

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

Water

Section 51945-4

Section 55105-1

Topical Anesthetic

Section 55106-9

Lidocaine 4%


Structured Label Content

Indications and Usage (34067-9)

Temporarily relieves minor pain.

Dosage and Administration (34068-7)

Adults and children 12 years of age and over: Clean and dry affected area.Carefully remove backing from patchstarting at a corner. Apply sticky side of patchto affected area. Use one patch for up to 12 hours. Discard patch aftersingleuse.Children under 12 years of age: consult a physician.

Warnings and Precautions (34071-1)

For external use only

Section 42229-5 (42229-5)

Lidocaine Patch

Section 44425-7 (44425-7)

Store in a clean, dry place outside of direct sunlight. Protect product form

excessive moisture.

Section 50565-1 (50565-1)

Keep out of reach of children and pets

Section 50566-9 (50566-9)

Stop use and consult 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.

Section 50567-7 (50567-7)

When using this product Use only as directed Read and follow alldirections and warings on this carton Do not allow contact with the eyes

Do not use at the same time as other topical analgesics

Do not bandage tightly orapply local heat (such as heating pads) to the area of use

Dispose of usedpatch inmanner that always keeps product away from children and pets, Used patches stil contain the drug product that can produce serious adverse effects ifa child or pet chews or ingests this patch.

Section 50570-1 (50570-1)

More than one patch on your body at a time

On cut, initated or swollen skin

On puncture wounds

For more than one week without consulting a doctor

lf you are allergic to any active or inactive ingredients lf pouch is damaged or opened.

Section 51727-6 (51727-6)

Aluminum Glycinate

Aluminum Hydroxide

Cellulose Gum

DMDM hydantoin

Glycerin

Polyacrylic Acid

Polysorbate 80

Propylene Glycol

Ricinus Communis Seed Oil (castor)

Silica

Sodium Polyacrylate

Tartaric Acid

Titanium Dioxide

Urea

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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