AspeFlex Tough on Pain Lidocaine Patch 4%

Manufacturer: Akron Pharma Inc.
Effective date: 2025-02-10
Label type: HUMAN OTC DRUG LABEL
Version: 3
Source: full-release
Hydrated at: 2026-06-01 00:55:06

Label at a glance#

ProductAsperFlex

Active ingredientLIDOCAINE

Label structure9 sections

Indications and uses

for the temporary relief of pain

Dosage and administration

a dults and children over 12 years: clean and dry affected area remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area use 1 patch at ...

Storage and handling

store at room temperature 15°-30°C (59°-86°F).

Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-255-6999

Websitewww.akronpharma.com

www.akronpharma.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Lidocaine 4%

Purpose

OTC - PURPOSE SECTION

Topical anesthetic

Uses

INDICATIONS & USAGE SECTION

for the temporary relief of pain

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

on puncture wounds, cuts, irritated or swollen skin
more than 1 patch on your body at a time or with other topical analgesics at the same time
with a heating pad or apply local heat to the area of use

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 bandage tightly or apply local heat (such as heating pads) to the area of use
do not use at the same time as other topical analgesics
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 ask a doctor if

OTC - STOP USE SECTION

condition worsens or symptoms persist for more than 7 days
symptoms clear up and occur again within a few days
redness or irritation develops
you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied

If pregnant or breast-feeding,

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 right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children over 12 years:

clean and dry affected area
remove backing from patch by firmly grasping both ends and gently pulling until backing separates in middle
carefully remove smaller portion of backing from patch and apply exposed portion of patch to affected area
once exposed portion of patch is positioned, carefully remove remaining backing to completely apply patch to affected area
use 1 patch at a time and not more than 3 to 4 times daily

children 12 years or younger: consult a doctor

Other Information

STORAGE AND HANDLING SECTION

store at room temperature 15°-30°C (59°-86°F).

Inactive ingredients

INACTIVE INGREDIENT SECTION

Dihydroxyaluminum Aminoacetate Anhydrous, Edetate Disodium, Glycerin, Kaolin, Methylparaben, Polyacrylic Acid, Polysorbate 80, Propylene Glycol, Propylparaben, PolyvinylPyrrolidone K90, Sodium Polyacrylate, Tartaric Acid, Titanium Dioxide, Water.

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

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
1737778	lidocaine 4 % Medicated Patch	PSN	3
1737778	lidocaine 0.04 MG/MG Medicated Patch	SCD	3
1737778	lidocaine 4 % Medicated Patch	SY	3

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
LIDOCAINE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
f52be47f-7aa7-46c0-b1fa-50c18dd50206	Product name	1	20201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
71399-4456-5	2025-02-11	C162847	48780-1	f386c64a-0d23-0266-e053-dadaa90a7c1a	AspeFlex Tough on Pain Lidocaine Patch 4%
71399-4456-5	2024-07-30	C162847	48780-1	f386c64a-0d23-0266-e053-dadaa90a7c1a	AspeFlex Tough on Pain Lidocaine Patch 4%
71399-4456-5	2023-02-19	C162847	48780-1	f386c64a-0d23-0266-e053-dadaa90a7c1a	AspeFlex Tough on Pain Lidocaine Patch 4%
71399-4456-5	2023-01-30	C162847	48780-1	f386c64a-0d23-0266-e053-dadaa90a7c1a	AspeFlex Tough on Pain Lidocaine Patch 4%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	SPL version
71399-4456-3	AsperFlex	0.246 g in 1 PATCH	PATCH	0.246	3
71399-4456-3	AsperFlex	30 in 1 CARTON	PATCH	30	3
71399-4456-5	AsperFlex	5 in 1 CARTON	PATCH	5	3
71399-4456-5	AsperFlex	0.246 g in 1 PATCH	PATCH	0.246	3

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
71399-4456	ASPERFLEX (LIDOCAINE) PATCH [AKRON PHARMA INC.]	3	Current NDC, Legacy NDC, 4 package rows	20250214_ab50525e-b534-452b-8c25-2992c0cbf862.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
71399-4456-3	EA - Each	71399-4456	c609add2-cdb7-4c61-baa0-c47147832582	1	2025-10-14
71399-4456-5	EA - Each	71399-4456	90427270-bab0-4662-a935-89631eaa3951	1	2022-01-06

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

AsperFlex
Lidocaine
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS
GLYCERIN
EDETATE DISODIUM
KAOLIN
METHYLPARABEN
POLYACRYLIC ACID (250000 MW)
POLYSORBATE 80
PROPYLENE GLYCOL
PROPYLPARABEN
POVIDONE K90
SODIUM POLYACRYLATE (2500000 MW)
TARTARIC ACID
TITANIUM DIOXIDE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
71399-4456	71399-4456-5, 71399-4456-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
LIDOCAINE	98PI200987	ACTIB
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS	1K713C615K	IACT
GLYCERIN	PDC6A3C0OX	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
KAOLIN	24H4NWX5CO	IACT
METHYLPARABEN	A2I8C7HI9T	IACT
POLYACRYLIC ACID (250000 MW)	9G2MAD7J6W	IACT
POLYSORBATE 80	6OZP39ZG8H	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
PROPYLPARABEN	Z8IX2SC1OH	IACT
POVIDONE K90	RDH86HJV5Z	IACT
SODIUM POLYACRYLATE (2500000 MW)	05I15JNI2J	IACT
TARTARIC ACID	W4888I119H	IACT
TITANIUM DIOXIDE	15FIX9V2JP	IACT
WATER	059QF0KO0R	IACT

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
AsperFlex	LIDOCAINE	Akron Pharma Inc.	ab50525e-b534-452b-8c25-2992c0cbf862	2025-02-10	Warnings	Exact identifier ndc (package): 71399-4456-3 ndc (package): 71399-4456-5 ndc (product): 71399-4456 ndc11 (package): 71399445605 ndc11 (package): 71399445603 spl id: bc8a5183-bc62-4d5b-8276-3a8e4c710b73 spl set id: ab50525e-b534-452b-8c25-2992c0cbf862

Reported adverse events (FAERS/openFDA)#

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