Lidocaine Patch

Manufacturer
SLV PHARMACEUTICALS LLC DBA AUM PHARMACEUTICALS
Effective date
2021-07-05
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:41:26

Label at a glance#

ProductLidocaine Patch
Active ingredientMENTHOL, LIDOCAINE
Label structure13 sections

Dosage and administration

Directions: Adults and children 12 years of age and over: C lean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Discard patch after single use. Do not expose area to heat. Children under 12 years of age: Consult a physician.

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Menthol 1%   . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . Topical Anesthetic

Purpose

OTC - PURPOSE SECTION

For temporary relief of minor pain.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions: Adults and children 12 years of age and over: Clean and dry affected area. Apply immediately upon removal from pouch. Peel off the first liner and apply exposed patch to affected area. Peel off second liner while applying the rest of patch. Remove patch after 24 hours. Discard patch after single use. Do not expose area to heat.

Children under 12 years of age: Consult a physician.

Warnings

WARNINGS SECTION

For external use only.

Do not use

OTC - DO NOT USE SECTION

■ if you are allergic to any active or inactive ingredients of this product

■ on wounds or damaged, irretated, or sensitive skin

■ with any other topical anesthetic

■ for more than one week without consulting a doctor

■ with a heating pad

■ if pouch is damaged or open

When using this product

OTC - WHEN USING SECTION

■ do not allow contact with the eyes

■ use only as directed, read and follow all directions and warnings on this package

■ do not bandage tightly or apply local heat

■ Used patches still contain the drug product that can produce serious adverse effects if a child or pet chews or ingests this patch.

■ do not reuse patch

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ symptoms persist for more than seven days or clear up and occur again within a few days

■ condition worsens

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Keep out of reach of children and pets.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Other Safety Information

Store in a clean, dry place outside of direct sunlight.  Store in original unopened pouch protected from moisture.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

alicyclic hydrocarbon resin, mineral oil, polyester film, silicon-coated polyester film and styrene isoprene styrene block copolymer.

Questions

OTC - QUESTIONS SECTION

Questions? 1-866-760-6565, Monday - Friday 8:30 a.m - 4:30 p.m. EST

Manufactured for:
AUM Pharmaceuticals
Hauppauge, NY 11788


Made in USA From Domestic and Imported Components

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Carton ImageCarton Image

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73317-6863-52024-08-29C16284748780-1f386c649-dccf-0266-e053-dadaa90a7c1aLidocaine 4% Plus Manthol 1% Patch 24 Hours
73317-6863-52023-01-30C16284748780-1f386c649-dccf-0266-e053-dadaa90a7c1aLidocaine 4% Plus Manthol 1% Patch 24 Hours

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
73317-6863-5EA - Each73317-6863d98f7775-b236-44fd-bbd1-41d8f901150a12021-09-07

Products#

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

DailyMed product names page 1 of 1 · 7 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73317-686373317-6863-5

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 matching rows.

Source Document#

Source XML

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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
16dee62b-544e-4ab9-ab77-fdc2fed255a5aa090bc7-bcdb-4ecf-8071-e17f61952f702024-08-29WarningsExact identifier
spl set id: aa090bc7-bcdb-4ecf-8071-e17f61952f70

Reported adverse events (FAERS/openFDA)#

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