FDA.reportPublic FDA data

Flexilon

Manufacturer
Semprae Laboratories Inc
Effective date
2022-12-31
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:24

Label at a glance#

ProductFlexilon
Active ingredientMENTHOL, CAMPHOR (SYNTHETIC), METHYL SALICYLATE
Label structure12 sections

Indications and uses

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

Dosage and administration

use only as directed  Adults and children 12 years of age and older : Apply to affected area not more than 3 to 4 times daily. Children under 12 years of age : consult a doctor.

Label contents#

Full prescribing information#

ACTIVE INGREDIENT

OTC - ACTIVE INGREDIENT SECTION

Camphor 4%

Menthol 7.5%

Methyl Salicylate 10%

PURPOSE

OTC - PURPOSE SECTION

Topical analgesic

USES

INDICATIONS & USAGE SECTION

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

  • simple backache
  • arthritis
  • strains
  • bruises
  • sprains

WARNINGS

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • on wounds or damaged , broken or irritated skin 
  • with a heating pad

When using this product

OTC - WHEN USING SECTION

  • avoid contact with eyes or mucous membranes 
  • do not bandage tightly

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens 
  • you have redness over the affected area 
  • symptoms persist for more than 7 days or symptoms clear up and occur within a few days 
  • excessive skin irritation occurs

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Center immediately

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • use only as directed 
  • Adults and children 12 years of age and older: Apply to affected area not more than 3 to 4 times daily.
  • Children under 12 years of age: consult a doctor.

OTHER INFORMATION

OTHER SAFETY INFORMATION

store at 20-25C (68-77F)

Do not purchase if outer seal is broken

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

carbomer, cetearyl alcohol, D.I. water, FD&C Blue no. 1, FD&C Yellow no.5, glucosamine sulfate, glyceryl monostearate, methyl sulfonyl methane,
methylparaben, mineral oil 90, PEG-100, propylparaben, polysorbate 60, stearyl alcohol, triethanolamine

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1998770camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical CreamPSN2
1998770camphor 40 MG/ML / menthol 75 MG/ML / methyl salicylate 100 MG/ML Topical CreamSCD2
1998770camphor 4 % / menthol 7.5 % / methyl salicylate 10 % Topical CreamSY2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72826-101-142025-01-30C16284748780-1d6a99b39-7f21-a426-e053-dadaa90af4c2dba920f3-27c8-4f69-a524-f99e57a276a0
72826-101-142023-01-19C16284748780-1d6a99b39-7f21-a426-e053-dadaa90af4c2dba920f3-27c8-4f69-a524-f99e57a276a0
72826-101-142022-01-28C16284748780-1d6a99b39-7f21-a426-e053-dadaa90af4c2dba920f3-27c8-4f69-a524-f99e57a276a0

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72826-101-14Flexilon56.7 g in 1 CONTAINERCREAM56.72
72826-101-14Flexilon1 in 1 CARTONCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72826-101FLEXILON (METHYL SALICYLATE, MENTHOL, CAMPHOR) CREAM [SEMPRAE LABORATORIES INC]2Legacy NDC, 2 package rows20230121_dba920f3-27c8-4f69-a524-f99e57a276a0.zip

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72826-10172826-101-14

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
MENTHOLL7T10EIP3AACTIB
CAMPHOR (SYNTHETIC)5TJD82A1ETACTIB
METHYL SALICYLATELAV5U5022YACTIB
WATER059QF0KO0RIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
PEG-100 STEARATEYD01N1999RIACT
MINERAL OILT5L8T28FGPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLPARABENZ8IX2SC1OHIACT
DIMETHYL SULFONE9H4PO4Z4FTIACT
TROLAMINE9O3K93S3TKIACT
CARBOMER 9404Q93RCW27EIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
FD&C YELLOW NO. 5I753WB2F1MIACT
GLUCOSAMINE SULFATE1FW7WLR731IACT
STEARYL ALCOHOL2KR89I4H1YIACT

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
806ad904-35cf-46f6-b9bb-1aa282c80866dba920f3-27c8-4f69-a524-f99e57a276a02022-12-31WarningsExact identifier
spl id: 806ad904-35cf-46f6-b9bb-1aa282c80866
spl set id: dba920f3-27c8-4f69-a524-f99e57a276a0

Reported adverse events (FAERS/openFDA)#

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