FDA.reportPublic FDA data

AsperFlex Tough on Pain Advance Pain Relieving Patch

Manufacturer
Akron Pharma Inc.
Effective date
2025-10-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:15:30

Label at a glance#

ProductAsperFlex Advance
Active ingredientCAMPHOR (SYNTHETIC), MENTHOL, METHYL SALICYLATE
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscles and joints associated with: arthritis simple backache strains bruises sprains

Dosage and administration

Adults and children 12 years of age and over: clean and dry affected area remove patch from film apply to affected area not more than 3 to 4 times daily remove patch from the skin after at most 8-hour application Children under 12 years of age: consult a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor 3.1%

Menthol 6.0%

Methyl salicylate 10.0%

Purpose

OTC - PURPOSE SECTION

Topical analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscles and joints associated with:

  • arthritis
  • simple backache
  • strains
  • bruises
  • sprains

Warnings

WARNINGS SECTION

For external use only

Allergy alert:

OTC - ASK DOCTOR SECTION

If prone to allergic reaction from aspirin or salicylates, consult a doctor before use.

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged skin
  • with a heating pad
  • if you are allergic to any ingredients of this product

When using this product

OTC - WHEN USING SECTION

  • use only as directed
  • avoid contact with the eyes, mucous membranes or rashes
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • rash, itching or excessive skin irritation develops
  • contisions worsen
  • symptoms persist for more than 7 days
  • symptoms clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children 12 years of age and over:

  • clean and dry affected area
  • remove patch from film
  • apply to affected area not more than 3 to 4 times daily
  • remove patch from the skin after at most 8-hour application

Children under 12 years of age:consult a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aluminum glycinate, propylene glycol, sodium acrylate/sodium acryloyldimethyl taurate copolymer, tartaric acid, 2,4-Imidazolidinedione, disodium edta, water, glycerin

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

Carton LabelCarton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchPSN4
1793147camphor 0.031 MG/MG / menthol 0.06 MG/MG / methyl salicylate 0.1 MG/MG Medicated PatchSCD4
1793147camphor 3.1 % / menthol 6 % / methyl salicylate 10 % Medicated PatchSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
71399-4458-62025-10-01C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch
71399-4458-62024-07-30C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch
71399-4458-62023-02-19C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch
71399-4458-62023-01-30C16284748780-1f386c64a-3f98-0266-e053-dadaa90a7c1aAsperFlex Tough on Pain Advance Pain Relieving Patch

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
71399-4458-6AsperFlex Advance1 in 1 PATCHPATCH14
71399-4458-6AsperFlex Advance6 in 1 BOXPATCH64

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71399-4458-6EA - Each71399-4458a38538b9-edd2-459f-92a9-a849a60c5ae312022-01-06

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71399-445871399-4458-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DIHYDROXYALUMINUM AMINOACETATE ANHYDROUS1K713C615KIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM ACRYLATE7C98FKB43HIACT
TARTARIC ACIDW4888I119HIACT
HYDANTOINI6208298TAIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
MENTHOLL7T10EIP3AACTIB
METHYL SALICYLATELAV5U5022YACTIB

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
AsperFlex AdvanceCAMPHOR, MENTHOL, METHYL SALICYLATEAkron Pharma Inc.d23d7f2b-4dcd-4c31-9d12-340f233018b42025-10-01WarningsExact identifier
ndc (package): 71399-4458-6
ndc (product): 71399-4458
ndc11 (package): 71399445806
spl id: 40203da6-76b4-e5f5-e063-6394a90ab7b3
spl set id: d23d7f2b-4dcd-4c31-9d12-340f233018b4

Reported adverse events (FAERS/openFDA)#

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