FDA.reportPublic FDA data

Flex24 Pain

Manufacturer
Flex24, Inc.
Effective date
2022-01-26
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:47:39

Label at a glance#

ProductFlex24 Pain
Active ingredientCAMPHOR (NATURAL), MENTHOL
Label structure11 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older: Apply to the affected area not more than 3 times daily Children under 2 years old: consult a doctor Tear and apply in a circle of 25 mm diameter to affected area and spread smoothly over the skin with fingers Wash fingers that applied cream with water.  Do not rub eyes with fingers until washed with water

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Menthol, 10%

Camphor, 3%

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, bruises, and sprains

Warnings

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 if

OTC - STOP USE SECTION

conditions worsens or if symptoms persist for more than 7 days

Caution

WARNINGS AND PRECAUTIONS SECTION

  • Discontinue use if there is redness or excessive irritation on skin
  • Avoid contact with eyes
  • Arthritis: If pain persists 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 the 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: Apply to the affected area not more than 3 times daily
  • Children under 2 years old: consult a doctor
  • Tear and apply in a circle of 25 mm diameter to affected area and spread smoothly over the skin with fingers
  • Wash fingers that applied cream with water.  Do not rub eyes with fingers until washed with water

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe Barbadensis leaf (Aloe Vera Gel) Juice, Aqua (Deionized water), Arnica Montana flower extract, Ascorbic Acid (Vitamin C), Beta Glucan, Boswellia Extract, Ceramide NG, Cetearyl Olivate, Cetyl Alcohol, Chamomilla Recutita (Chamomile) Extract, Cucumis Sativus (Cucumber) Fruit Extract, Distearyldimonium Chloride, Gluconolactone, Glyceryl Stearate, Glycerin, Helianthus Annuus (sunflower) oil, Lactic acid, Magnesium Sulfate, Melaleuca Alternifolia (Tea tree) oil, Xanathan Gum, Methylsulfonylmethane (MSM), PPG 12/SMD1 copolymer, Retinyl Palmitate (Vitamin A), Saccharide Isomerate, SD-Alcohol 40B, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

FLEX24

RECOVER NATURALLY

PAIN CREAM

SAMPLE PACK

NET wt. 0.14 oz (3.8g)

Dist: FLEX24, INC.

4020 GALT OCEAN DRIVE, STE. 1607

FORT LAUDERDALE, FL 33308

CALL TOLL FREE 844.4.FLEX24

NDC 73218-001-01

20190927 Flex24Inc_Pain_Cream20190927 Flex24Inc_Pain_Cream

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2118541camphor 3 % / menthol 10 % Topical CreamPSN2
2118544FLEX24 3 % / 10 % Topical CreamPSN2
2118544camphor 30 MG/ML / menthol 100 MG/ML Topical Cream [Flex24 Performance]SBD2
2118541camphor 30 MG/ML / menthol 100 MG/ML Topical CreamSCD2
2118541camphor 3 % / menthol 10 % Topical CreamSY2
2118544Flex24 3 % / 10 % Topical CreamSY2

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
73218-001-012024-01-30C16284748780-11030e365-4899-111a-e063-dadaa90a10e29a7e5861-3ece-46b8-a1b5-b4b633dba185

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
73218-001-01Flex24 Pain3.8 g in 1 PACKETCREAM3.82

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
73218-001FLEX24 PAIN (CAMPHOR, MENTHOL) CREAM [FLEX24, INC.]2Legacy NDC, 1 package rows20220127_9a7e5861-3ece-46b8-a1b5-b4b633dba185.zip

Products#

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

DailyMed product names page 1 of 1 · 35 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
73218-00173218-001-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
GLUCAN ENDO-1,3-.ALPHA.-GLUCOSIDASE AGN1808D59AO7CIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
CERAMIDE NGC04977SRJ5IACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
MATRICARIA CHAMOMILLAG0R4UBI2ZZIACT
CUCUMIS SATIVUS WHOLE50560UL2YVIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERINPDC6A3C0OXIACT
HELIANTHUS ANNUUS WHOLE17S27ZT6KRIACT
LACTIC ACID33X04XA5ATIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
MELALEUCA ALTERNIFOLIA WHOLE976KV4FXYFIACT
XANTHAN GUMTTV12P4NEEIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
PPG-12/SMDI COPOLYMER1BK9DDD24EIACT
VITAMIN A81G40H8B0TIACT
SACCHARIDE ISOMERATEW8K377W98IIACT
ALCOHOL3K9958V90MIACT
denatonium benzoate4YK5Z54AT2IACT
tert-butyl alcoholMD83SFE959IACT
SODIUM BENZOATEOJ245FE5EUIACT
SORBITAN OLIVATEMDL271E3GRIACT
STARCH, TAPIOCA24SC3U704IIACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PROPANEDIOL5965N8W85TIACT

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
6ffba4dc-9f36-4e29-a7f3-be33aa31a9cc9a7e5861-3ece-46b8-a1b5-b4b633dba1852022-01-26WarningsExact identifier
spl id: 6ffba4dc-9f36-4e29-a7f3-be33aa31a9cc
spl set id: 9a7e5861-3ece-46b8-a1b5-b4b633dba185

Reported adverse events (FAERS/openFDA)#

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