FDA.reportPublic FDA data

Flex24 Pain

Manufacturer
FLEX24 INC
Effective date
2019-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:09

Label at a glance#

ProductFlex24 Pain
Active ingredientCAMPHOR (NATURAL), MENTHOL
Label structure9 sections

Indications and uses

For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, cramps, bruises, and sprains.

Dosage and administration

Adults and children over the age of 12: Remove plastic backing from patch and discard Apply one patch to affected area Repeat if necessary, but no more than 3 per day Patch should be comfortable but not tight Sensitive skin – Remove patch under water Children under 12: consult a doctor before use

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Camphor, 3%

Menthol, 2.52%

Purpose

OTC - PURPOSE SECTION

Topical Analgesic

Uses

INDICATIONS & USAGE SECTION

For temporary relief of minor aches and pains of muscle and joints associated with simple backache, arthritis, strains, cramps, bruises, and sprains.

WARNINGS SECTION

For external use only

OTC - DO NOT USE SECTION

Do not

  • Apply to open wounds, or damaged, broken, or irritated skin
OTC - STOP USE SECTION

Stop use and ask a doctor if condition worsens or if there is redness or irritation in the applied area or if symptoms persist for more than 7 days or clear up and occur again within a few days.

WARNINGS AND PRECAUTIONS SECTION

Caution

  • Discontinue use if excessive irritation of the skin develops
  • Avoid contact with the eyes and mucous membranes
  • Arthritis: If pain persists for more than 10 days, or redness is present, or in conditions affecting children under 12 years of age, consult a physician immedately

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Adults and children over the age of 12:

  • Remove plastic backing from patch and discard
  • Apply one patch to affected area
  • Repeat if necessary, but no more than 3 per day
  • Patch should be comfortable but not tight
  • Sensitive skin – Remove patch under water

Children under 12: consult a doctor before use

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Angelica Dahurica Root, Atractylodes Lancea Root, Borneol, Chinese Angelica, Chondroitin Sulfate, Ginger, Kaempferia Galanga Root, Kusnezoff Monkshood Root (raw), Lemon, Ligusticum Sinense/Subsp. Chuanxiong Root, Mineral Oil, Musk, Petrolatum, Radix Aconiti, Rosin, Silicone, Star Anise, Wintergreen Oil, Zinc Oxide

SPL UNCLASSIFIED SECTION

Download the FLEX24 App

Dist: FLEX24, INC.

        4020 Galt Ocean Mile, Ste. 1607

        Ft. Lauderdale, FL 33308

       Tel: 844.4.FLEX24

Formulated in the USA

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLEX24.COM

FLEX24®

RECOVER NATURALLY

TOPICAL ANALGESIC PAIN PATCH

24 Hour Relief

7 Large Patches

Patch size 8 cm x 13 cm

All Natural

Long Lasting

Reduces Pain

Strong Natural Pain Relief

20190828_73218_patch20190828_73218_patch

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1364993camphor 3 % / menthol 2.52 % Medicated PatchPSN1
1494222FLEX24 PERFORMANCE 3 % / 2.52 % Medicated PatchPSN1
1494222camphor 0.03 MG/MG / menthol 0.0252 MG/MG Medicated Patch [Flex24 Performance]SBD1
1364993camphor 0.03 MG/MG / menthol 0.0252 MG/MG Medicated PatchSCD1
1364993camphor 3 % / menthol 2.52 % Medicated PatchSY1
1494222Flex24 Performance (camphor 3 % / menthol 2.52 % ) Medicated PatchSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73218-002-012022-01-28C16284748780-1d6a99b39-9ef1-a426-e053-dadaa90af4c25668d4cb-c938-435c-81d9-a1bbf8c67f68

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73218-002-01Flex24 Pain7 in 1 PACKAGEPATCH71
73218-002-01Flex24 Pain1.56 g in 1 PATCHPATCH1.561

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73218-002FLEX24 PAIN (CAMPHOR, MENTHOL) PATCH [FLEX24 INC]1Legacy NDC, 2 package rows20190829_5668d4cb-c938-435c-81d9-a1bbf8c67f68.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73218-00273218-002-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 20 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB
ANGELICA DAHURICA ROOT1V63N2S972IACT
ATRACTYLODES LANCEA ROOTCAZ6282J2OIACT
BORNEOLM89NIB437XIACT
ANGELICA SINENSIS ROOTB66F4574UGIACT
CHONDROITIN SULFATE (BOVINE)6IC1M3OG5ZIACT
GINGERC5529G5JPQIACT
KAEMPFERIA GALANGA ROOT7B7U9D12AIIACT
ACONITUM KUSNEZOFFII ROOT3L29I4K8KXIACT
LEMON24RS0A988OIACT
LIGUSTICUM SINENSE SUBSP. CHUANXIONG ROOTRR83T99U97IACT
MINERAL OILT5L8T28FGPIACT
MOSCHUS BEREZOVSKII MUSK SAC RESINZ70MFY52S4IACT
PETROLATUM4T6H12BN9UIACT
ACONITUM NAPELLUS ROOTKPD2N7348XIACT
ROSIN88S87KL877IACT
STAR ANISEXKC1657P78IACT
METHYL SALICYLATELAV5U5022YIACT
ZINC OXIDESOI2LOH54ZIACT

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
201c4363-44f3-40bf-93b8-a3f3d0f4e5b15668d4cb-c938-435c-81d9-a1bbf8c67f682019-08-28WarningsExact identifier
spl id: 201c4363-44f3-40bf-93b8-a3f3d0f4e5b1
spl set id: 5668d4cb-c938-435c-81d9-a1bbf8c67f68

Reported adverse events (FAERS/openFDA)#

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