FDA.reportPublic FDA data

ASPERFLEX 24 Hour Lidocaine Patch

Manufacturer
Akron Pharma Inc.
Effective date
2023-02-12
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:54:10

Label at a glance#

ProductASPERFLEX 24HRS
Active ingredientLIDOCAINE
Label structure4 sections

Dosage and administration

Directions Adults and children over 12 years: clean and dry affected area carefully remove backing from patch starting at corner apply sticky side of patch to affected area use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician. For external use only. Uses: Temporaily relieves minor pains. When using this product use only as directed read and follow a...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

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

Purpose

OTC - PURPOSE SECTION

Temporarily relieves minor pain.

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

Directions Adults and children over 12 years:

  • clean and dry affected area
  • carefully remove backing from patch starting at corner
  • apply sticky side of patch to affected area
  • use one patch for up to 24 hours. Discard patch after single use. Children under 12 years of age: consult a physician.

Warnings

WARNINGS SECTION

For external use only.

Idications and Usage

INDICATIONS & USAGE SECTION

Uses: Temporaily relieves minor pains.

OTC - WHEN USING SECTION

When using this product

  • 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Stop use and consult a doctor

  • 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, ask a health professional before use.

Do not Use

OTC - DO NOT 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.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets.

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

OTHER SAFETY INFORMATION

Other Safety Information

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

INACTIVE INGREDIENT SECTION

Inactive Ingredients

Alicyclic Hydrocarbon Resin, Mineral Oil, Polyester film, Silicone –coated polyester film and styrene isoprene styrene block copolymer

NDC: 71399-3884-6

Package size: 6 Patches

Questions?

OTC - QUESTIONS SECTION

Please Call 1(877) 225-6999

Manufactured for:
Akron Pharma, Inc.
Fairfield, NJ 07004
Manufactured in U.S.A

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1737778lidocaine 4 % Medicated PatchPSN2
1737778lidocaine 0.04 MG/MG Medicated PatchSCD2
1737778lidocaine 4 % Medicated PatchSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-3884-12025-01-30C16284748780-1f386c64a-106d-0266-e053-dadaa90a7c1aASPERFLEX 24 Hour Lidocaine Patch
71399-3884-12023-02-19C16284748780-1f386c64a-106d-0266-e053-dadaa90a7c1aASPERFLEX 24 Hour Lidocaine Patch
71399-3884-12023-01-30C16284748780-1f386c64a-106d-0266-e053-dadaa90a7c1aASPERFLEX 24 Hour Lidocaine Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-3884-1ASPERFLEX 24HRS1 in 1 PACKAGEPATCH12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-3884ASPERFLEX 24HRS (LIDOCAINE PATCH 4%) PATCH [AKRON PHARMA INC.]2Legacy NDC, 1 package rows20230220_b96e83a5-2aa2-436d-b80b-6fcb701ef12a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-3884-6EA - Each71399-3884bf8fed9a-657a-4b28-8655-89ed05d8647a12021-03-02

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-388471399-3884-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 3 matching rows.

Name, UNII, Kind table
NameUNIIKind
MINERAL OILT5L8T28FGPIACT
STYRENE/ISOPRENE/STYRENE BLOCK COPOLYMERK7S96QM8DVIACT
LIDOCAINE98PI200987ACTIB

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
71ba4ef8-57e3-446e-8d0f-ecd766604a94b96e83a5-2aa2-436d-b80b-6fcb701ef12a2023-02-12WarningsExact identifier
spl id: 71ba4ef8-57e3-446e-8d0f-ecd766604a94
spl set id: b96e83a5-2aa2-436d-b80b-6fcb701ef12a

Reported adverse events (FAERS/openFDA)#

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