FDA.reportPublic FDA data

Flex24 Pain

Manufacturer
Larasan Pharmaceutical Corporation | Dong E E Hua Medical Technology Co., Ltd.
Effective date
2019-02-22
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:02:08

Label at a glance#

ProductFlex24 Pain
Active ingredientCAMPHOR (NATURAL), MENTHOL
Label structure10 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 2 years of age or older: Apply to affected area as and when required. • Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) 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. • Children under 2 years old: consult a doctor

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, cramps, 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

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.

Caution

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 or older: Apply to affected area as and when required.
• Remove the cap and apply in a circle of 25 mm diameter (size of a quarter) 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.
• Children under 2 years old: consult a doctor

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 4013, Sodium Benzoate, Sorbitan Olivate, Tapioca Starch, Tocopheryl Acetate (Vitamin E), Zemea (Corn) Propanediol

Other Information

SPL UNCLASSIFIED SECTION

Keep sealed in a dry environment at no more than 85°F/29°C and avoid any direct sun exposure

SPL UNCLASSIFIED SECTION

Larasan Pharmaceutical Corp.

1287 E. Newport Center Drive, Suite 206

Deerfield Beach, FL 33442

Made in USA

54641-008-01

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Pain Cream

Pain Relief

  • Long Lasting
  • Invisible
  • No smell

3.4 oz (96 g)

  • Fast and Long-Lasting Pain Relief
  • Smooth, Non-Sticky, Pleasant Smell
  • Invsible Relief for Hours

Flex24(r)

Recover Naturally

20190218 54641_008_0120190218 54641_008_01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2118541camphor 3 % / menthol 10 % Topical CreamPSN1
2118544FLEX24 3 % / 10 % Topical CreamPSN1
2118544camphor 30 MG/ML / menthol 100 MG/ML Topical Cream [Flex24 Performance]SBD1
2118541camphor 30 MG/ML / menthol 100 MG/ML Topical CreamSCD1
2118541camphor 3 % / menthol 10 % Topical CreamSY1
2118544Flex24 3 % / 10 % Topical CreamSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
c5cd4727-ac49-4409-82b1-5bd8006c3ec7Product name120171122
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
54641-008-012021-01-29C16284748780-1ba0f9c33-5727-a910-e053-dadaa90a0b8506f4e017-93d2-40fb-8965-93d9c2a915e7

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
54641-008-01Flex24 Pain96 g in 1 CONTAINERCREAM961

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
54641-008FLEX24 PAIN (CAMPHOR MENTHOL) CREAM [LARASAN PHARMACEUTICAL CORPORATION]1Legacy NDC, 1 package rows20190225_06f4e017-93d2-40fb-8965-93d9c2a915e7.zip

Products#

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

DailyMed product names page 1 of 1 · 36 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
54641-00854641-008-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 34 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAMPHOR (NATURAL)N20HL7Q941ACTIB
MENTHOLL7T10EIP3AACTIB
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
ARNICA MONTANAO80TY208ZWIACT
ASCORBIC ACIDPQ6CK8PD0RIACT
GLUCAN ENDO-1,3-.ALPHA.-GLUCOSIDASE AGN1808D59AO7CIACT
BOSWELLIA SERRATA WHOLEX7B7P649WQIACT
CERAMIDE NGC04977SRJ5IACT
CETEARYL OLIVATE58B69Q84JOIACT
CETYL ALCOHOL936JST6JCNIACT
MATRICARIA CHAMOMILLA LEAF6I9LN466F0IACT
CUCUMIS SATIVUS WHOLE50560UL2YVIACT
DISTEARYLDIMONIUM CHLORIDEOM9573ZX3XIACT
GLUCONOLACTONEWQ29KQ9POTIACT
GLYCERYL STEARATE SEFCZ5MH785IIACT
GLYCERINPDC6A3C0OXIACT
SUNFLOWER OIL3W1JG795YIIACT
LACTIC ACID, L-F9S9FFU82NIACT
MAGNESIUM SULFATE ANHYDROUSML30MJ2U7IIACT
TEA TREE OILVIF565UC2GIACT
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 ACETATE9E8X80D2L0IACT
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
437c2b27-4ecb-4592-8cc9-6d72bfe35d1906f4e017-93d2-40fb-8965-93d9c2a915e72019-02-22WarningsExact identifier
spl id: 437c2b27-4ecb-4592-8cc9-6d72bfe35d19
spl set id: 06f4e017-93d2-40fb-8965-93d9c2a915e7

Reported adverse events (FAERS/openFDA)#

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