FDA.reportPublic FDA data

AsperFlex (Lidocaine 4% Ointment)

Manufacturer
Akron Pharma Inc.
Effective date
2024-09-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:19:58

Label at a glance#

ProductLidocaine
Active ingredientLIDOCAINE
Label structure14 sections

Indications and uses

Temporarily relieves minor pain & itching due to: minor cuts minor scrapes sunburn minor skin irritations minor burns insect bites

Dosage and administration

adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily. Children under 2 years: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine HCL 4%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

Temporarily relieves minor pain & itching due to:

  • minor cuts
  • minor scrapes
  • sunburn
  • minor skin irritations
  • minor burns
  • insect bites

Warnings

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not use

  • if you are allergice to any active or inactive ingredients of this product
  • on wonds or damaged, irritated, or sensitive skin
  • with any other topical anesthetic
  • for more than one week without constulting a doctor
  • over large areas of the body

OTC - WHEN USING SECTION

When using this product

  • do not use in or near the eyes
  • do not use in large quantities, particularly over raw surfaces or blistered areas

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • symptoms presist 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, readness, irritation, swelling or blistering

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children and pets. If chewed or swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years and older: Apply externally to the affected area up to 3-4 times daily.
  • Children under 2 years: Consult a doctor.

Other information

SPL UNCLASSIFIED SECTION

  • for topical use only
  • do not use in the eyes
  • Store are room temperature 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe vera, mineral oil, petrolatum white, phenoxyethanol, polysorbate 80, purified water.

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-255-6999

Childproof Packaging

Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing

Manufactured for:

Akron Pharma Inc.

Fairfield, Nj 07004

Visit at: www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Maximun Strength

NDC 71399-6544-1

AsperFlex™

Touch on Pain

Lidocaine 4% Ointment

Pain reliving Formula

Topical Analgesic

Numbs Away Pain

Made in the USA

NET WT 3.53 OZ (100g)

Lidocaine labelLidocaine label

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
71399-6544-12023-04-03C16284748780-1f386c649-cf3d-0266-e053-dadaa90a7c1aAsperFlex (Lidocaine 4% Ointment)
71399-6544-12023-01-30C16284748780-1f386c649-cf3d-0266-e053-dadaa90a7c1aAsperFlex (Lidocaine 4% Ointment)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-6544-1Lidocaine1 in 1 JAROINTMENT13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71399-6544LIDOCAINE OINTMENT [AKRON PHARMA INC.]3Legacy NDC, 1 package rows20240922_d22c8c01-1ba2-e9d3-e053-2995a90ac4f0.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-6544-1GM - Gram71399-6544f9834224-8643-4fd6-8c79-37907298aa8312022-03-09

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
71399-654471399-6544-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
POLYSORBATE 806OZP39ZG8HIACT
PHENOXYETHANOLHIE492ZZ3TIACT
WATER059QF0KO0RIACT
MINERAL OILT5L8T28FGPIACT
LIDOCAINE98PI200987ACTIB
WHITE PETROLATUMB6E5W8RQJ4IACT
ALOE VERA WHOLEKIZ4X2EHYXIACT

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
3ddfea43-cf5e-416a-8875-302973c48da1d22c8c01-1ba2-e9d3-e053-2995a90ac4f02024-09-18WarningsExact identifier
spl id: 3ddfea43-cf5e-416a-8875-302973c48da1
spl set id: d22c8c01-1ba2-e9d3-e053-2995a90ac4f0

Reported adverse events (FAERS/openFDA)#

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