FDA.reportPublic FDA data

Asper Flex

Manufacturer
Akron Pharma Inc.
Effective date
2025-09-19
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:14:07

Label at a glance#

ProductAsper Flex
Active ingredientLIDOCAINE
Label structure11 sections

Indications and uses

temporarily relieves pain and itching due to minor cuts minor scrapes minor burns sunburn minor skin irritation insect bites

Dosage and administration

Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day. Children under 2 years of age: Consult a doctor.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4% w/w

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

temporarily relieves pain and itching due to

  • minor cuts
  • minor scrapes
  • minor burns
  • sunburn
  • minor skin irritation
  • 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

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adult and children 2 years and older: Apply externally to the affected area up to 3 to 4 times a day.
  • Children under 2 years of age: Consult a doctor.

For external use only

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • in or near the eyes
  • in large quantities, particularly over raw or blistered areas

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • allergic reaction occurs
  • condition worsens or does not improve within 7 days
  • symptoms clear up and return within a few days
  • redness, irritation, swelling, pain or other symptoms begin or increase

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Other information

SPL UNCLASSIFIED SECTION

  • May be applied under occlusive dressing.
  • Store at room temperature, 20–25°C (68–77°F) Excursions permitted 15–30°C (59–86°F) [see USP Controlled Room Temperature].

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf juice, Benzyl alcohol, Carbomer, Cetostearyl alcohol, Cholesterol, Glycerin, lsopropyl myristate, Polysorbate 80, Propylene Glycol, Purified Water, Stearic acid, Tocopherol, Trolamine

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free 1-877-255-6999

Manufactured for:

Akron Pharma Inc.

Fairfield, NJ 07004

www.akronpharma.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1125g25g

30g30g

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1421893lidocaine 4 % Topical CreamPSN4
1421893lidocaine 40 MG/ML Topical CreamSCD4
1421893lidocaine 4 % Topical CreamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
070fbed5-7088-434a-a7ce-f2a64d8d40acProduct name220260107
bee66ce1-adb7-9d3b-67d9-582e4c54e80fProduct name520250819
860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
eaba870a-6a9d-442e-8643-87b3f558a451Product name120250117
9b4cf230-fd05-41d5-98c6-5db9ecb27b86Product name120230117
3c386306-c48a-413e-bb69-70cb268496f3Product name120210727
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
aed701d5-9c75-dfaf-7154-cde46179faeaProduct name920200313
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
c08ab52f-2fc8-4409-9d9f-ed8edc0bd070Product name120171221
68ed98f8-24c2-44a0-944a-6d36e82ce25aProduct name120141222
1cd42bc2-a430-c72b-636d-991b235fbf80Product name120140508
49fa150c-f0de-cce7-3d9c-993ed81c5698Product name120140508
4d7ae718-ed00-bae8-2abe-9eaec1eef7ffProduct name120140508
9137811f-f279-8640-5aeb-99fa2145d64dProduct name120140508
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-0049-1Asper Flex15 g in 1 PACKAGECREAM154
71399-0049-1Asper Flex1 in 1 CARTONCREAM14
71399-0049-2Asper Flex25 g in 1 PACKAGECREAM254
71399-0049-2Asper Flex1 in 1 CARTONCREAM14
71399-0049-3Asper Flex30 g in 1 PACKAGECREAM304
71399-0049-3Asper Flex1 in 1 CARTONCREAM14

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-0049-1GM - Gram71399-004968fb1116-978b-4dae-aec0-508ce597e8c212023-12-05
71399-0049-2GM - Gram71399-004958efdf6f-be30-4a3d-bf8f-7886384afcd512025-01-14
71399-0049-3GM - Gram71399-0049dc94c988-f326-4748-8034-b1ad7f9b33ef12023-12-05

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-004971399-0049-2, 71399-0049-3, 71399-0049-1

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
ALOE BARBADENSIS LEAFZY81Z83H0XIACT
BENZYL ALCOHOLLKG8494WBHIACT
CARBOMER0A5MM307FCIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHOLESTEROL97C5T2UQ7JIACT
GLYCERINPDC6A3C0OXIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TOCOPHEROLR0ZB2556P8IACT
TROLAMINE9O3K93S3TKIACT
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
Asper FlexLIDOCAINEAkron Pharma Inc.06ddae64-cda7-4eb9-872f-5182c83cb00c2025-09-19WarningsExact identifier
ndc (package): 71399-0049-3
ndc (package): 71399-0049-2
ndc (package): 71399-0049-1
ndc (product): 71399-0049
ndc11 (package): 71399004901
ndc11 (package): 71399004903
ndc11 (package): 71399004902
spl id: 3f2cef5f-9c8b-a1af-e063-6294a90a2e74
spl set id: 06ddae64-cda7-4eb9-872f-5182c83cb00c

Reported adverse events (FAERS/openFDA)#

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