FLEX24 PAIN PEN

Manufacturer
FLEX24, INC. | Dong E E Hua Medical Technology Co, Ltd
Effective date
2019-08-28
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:00:10

Label at a glance#

ProductFLEX24 PAIN PEN
Active ingredientCAMPHOR (NATURAL)
Label structure12 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older: • Remove plastic top from device and put aside till after treatment • Squeeze device if necessary and apply ointment to the affected area • Repeat as necessary but no more than 3 treatments per day Children under 2 years of age, consult a physician.

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Camphor, 7.79%

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 arthritis, strains, cramps, bruises, and sprains.

WARNINGS SECTION

​For external use only

Do not

OTC - DO NOT USE SECTION

• Apply to open wounds, or damaged, broken, or irritated skin

Stop use and ask a doctor

OTC - STOP USE SECTION

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.

Caution

WARNINGS AND PRECAUTIONS SECTION

• 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 immediately.

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 2 years of age and older:

• Remove plastic top from device and put aside till after treatment

• Squeeze device if necessary and apply ointment to the affected area

• Repeat as necessary but no more than 3 treatments per day

Children under 2 years of age, consult a physician.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aconitum Kusnezoffii Root, Angelica Dahurica Root, Angelica Sinesis Root, Asarum Heterotropoides var. Drynaria Fortunei Root, Eleutherococcus Nodiflorus Root Bark, Ethyl Alcohol, Eucalyptus Oil, Frosythia Suspensa Fruit, Frankincense, Gardenia Jasminoides Fruit, Lavender Oil, Lemon, Myrrh, Paeonia Suffruticosa Root Bark, Peppermint Oil, Pinellia Ternata Root, Red Paeonia Lactiflora Root, Rehmannia Glutinosa Root (Raw), Rhubarb, Safflower, Tangerine Peel, Turmeric, White Paeonia Lactiflora Root, Wintergreen Oil, Zanthoxylum Nitidum Root, Zeodary

SPL UNCLASSIFIED SECTION

FLEX24®

RECOVER NATURALLY

Dist: FLEX24, INC.

        4020 Galt Ocean Mile, Ste. 1607

        Ft. Lauderdale, FL 33308

        Tel.: 844.4.FLEX24

Formulated in USA

Made in China

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

ROLL-ON PEN

PAIN RELIEF

WORKS FOR ARTHRITIS

• ALL NATURAL

• FAST ACTING

• LONG LASTING

Topical Analgesic

0.61 fl. oz. (18 mL)

• Plant based medicine for pain relief

• Fast acting and long lasting

• Works for: aches, pains, & strains

FLEX24®

RECOVER NATURALLY

20190828_73218_PainPen20190828_73218_PainPen

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1365674camphor 7.79 % Topical SolutionPSN1
1601550Flex24 Pain Pen 7.79 % Topical SolutionPSN1
1601550camphor 0.779 MG/ML Topical Solution [Flex24]SBD1
1365674camphor 0.779 MG/ML Topical SolutionSCD1
1365674camphor 7.79 % Topical SolutionSY1
1601550Flex24 0.779 MG/ML Topical SolutionSY1
1601550Flex24 7.79 % Pain PenSY1

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73218-003-012022-01-28C16284748780-1d6a99b39-3637-a426-e053-dadaa90af4c294f27aa1-903e-4323-9cd5-6cfc59f7a63a

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73218-003-01FLEX24 PAIN PEN18 mL in 1 BOTTLE, WITH APPLICATORLIQUID181

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73218-003FLEX24 PAIN PEN (CAMPHOR) LIQUID [FLEX24, INC.]1Legacy NDC, 1 package rows20190829_94f27aa1-903e-4323-9cd5-6cfc59f7a63a.zip

Products#

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

DailyMed product names page 1 of 1 · 28 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73218-00373218-003-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 26 matching rows.

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
b5d6f0c4-0e92-48e5-8df5-68113d0a7e7f94f27aa1-903e-4323-9cd5-6cfc59f7a63a2019-08-28WarningsExact identifier
spl id: b5d6f0c4-0e92-48e5-8df5-68113d0a7e7f
spl set id: 94f27aa1-903e-4323-9cd5-6cfc59f7a63a

Reported adverse events (FAERS/openFDA)#

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