Lidocaine 4%

Label at a glance#

Contacts and useful links#

PhonePoison Help800-222-1222

PhoneLabel contact1-866-326-1313

PhoneLabel contact1-800-616-2471

Websitewww.majorpharmaceuticals.comwww.majorpharmaceuticals.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4.0%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Use

INDICATIONS & USAGE SECTION

Temporarily es minor pain.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

■ More than one patch on your body at a time

■ On cut, irritated or swollen skin

■ On puncture wounds

■ For more than one week without consulting a doctor

■ If you are allergic to any active or inactive ingredients

■ If pouch is damaged or opened.

When using this product

OTC - WHEN USING SECTION

■ Use only as directed

■ Read and follow all directions and warnings 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 or apply local heat (such as heating pads) to the area of use

■ Do not microwave

■ Dispose of used patch in manner that always keeps product away from children and pets. Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

Stop use and consult a doctor

OTC - STOP USE SECTION

• ■ 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 breastfeeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

Keep out of reach of children and pets

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center 800-222-1222 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children 12 years of age and over: Clean and dry affected area, free of lotions, ointments and creams. Carefully remove backing from patch starting at a corner. Apply sticky side of patch to affected area. Do not use more than one patch in a 12 hour period. Maximum 2 patches per day. Discard patch after single use. Children under 12 years of age: consult a physician.

Other safety information

Store in a clean, dry place outside of direct sunlight. Protect from excessive moisture.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

aluminum glycinate, glycerin, kaolin, methylparaben, polyacrylic acid, polysorbate 80, propylene glycol, propylparaben, PVP, sodium polyacrylate, tartaric acid, titanium dioxide, water

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-866-326-1313

.

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Chattem Inc., owner of the registered trademark Aspercream®.

Distributed by:

RUGBY® LABORATORIES

Undianapolis, IN 46268

Made in China

Questions or comments?

Call 1-800-616-2471

www.majorpharmaceuticals.com

Distributed By:

Cardinal Health

Dublin, OH 43017

L59206240624

Rev. 12/23

R-153

Re-order No. 371082

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-7813-5

LIDOCAINE PATCH 4%

MAXIMUM OTC STRENGTH

5 PATCHES

Related RxNorm Concepts#

DailyMed RxNorm Mappings#

DailyMed Pharmacologic Classes#

Product Linked Resources#

DailyMed Product Concepts#

DailyMed Package Descriptions#

DailyMed Billing Units#

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 15 matching rows.

• Lidocaine 4% Maximum OTC Strength
• Lidocaine
• DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS
• GLYCERIN
• KAOLIN
• METHYLPARABEN
• POLYACRYLIC ACID (300000 MW)
• POLYSORBATE 80
• PROPYLENE GLYCOL
• PROPYLPARABEN
• POVIDONE, UNSPECIFIED
• SODIUM POLYACRYLATE (2500000 MW)
• TARTARIC ACID
• TITANIUM DIOXIDE
• WATER

NDC Codes#

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

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Source XML

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openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.