FDA.reportPublic FDA data

FlexSport Roll On - Pharmadel LLC

Manufacturer
Pharmadel LLC
Effective date
2026-03-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:51:46

Label at a glance#

ProductFlexSport Roll On
Active ingredientMETHYL SALICYLATE
Label structure8 sections

Indications and uses

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

Dosage and administration

use only as directed adults and children over 12 years: apply to affected area not more than 3 to 4 times daily children under 12 years of age: ask a doctor

Label contents#

Full prescribing information#

Active ingredient and Purpose

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientPurpose
Menthol 16% ....................Topical analgesic

Uses

INDICATIONS & USAGE SECTION

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

  • arthritis
  • simple backache
  • muscle strains
  • sprains
  • bruises

Warnings

WARNINGS SECTION

For external use only. Avoid contact with the eyes.

Flammable: keep away from fire or flame.

When using this product

OTC - WHEN USING SECTION

  • do not bandage tightly or use with a heating pad
  • do not apply to wounds or damaged, broken or irritated skin

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • redness is present
  • irritation develops
  • symptoms persist for more than 7 days or clear up and occur again within a few days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed,get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • use only as directed
  • adults and children over 12 years: apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor

Other information

OTHER SAFETY INFORMATION

  • store at temperatures not exceeding 15°–30°C (59°– 86°F)
  • avoid excessive heat and humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

acrylates/C10-30 alkyl acrylate crosspolymer, alcohol, capsaicin, glycerin, isopropyl myristate, propylene glycol, trolamine, water

Questions or Comments?

OTC - QUESTIONS SECTION

1-866-359-3478 (M-F) 9 AM – 5 PM EST or www.pharmadel.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Topical Analgesic Liquid

FlexSport

Pain Relief

ROLL-ON

  • Muscle & Joint Pain
  • Backaches
  • Arthritis

3 fl oz (89 mL)

FS PDPFS PDP

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
473d070d-1c38-488e-b991-c4d1bf45aab8Product name120210201

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55758-360-03FlexSport Roll On1 in 1 BOXLIQUID14
55758-360-03FlexSport Roll On89 g in 1 BOTTLE, WITH APPLICATORLIQUID894

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-36055758-360-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
CAPSAICINS07O44R1ZMIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ISOPROPYL ALCOHOLND2M416302IACT
MENTHOLL7T10EIP3AIACT
POLYSORBATE 207T1F30V5YHIACT
ALPHA-TOCOPHEROL ACETATE9E8X80D2L0IACT
CAMPHOR (SYNTHETIC)5TJD82A1ETIACT
POLYACRYLIC ACID (250000 MW)9G2MAD7J6WIACT
DMDM HYDANTOINBYR0546TOWIACT
ARNICA MONTANA FLOWEROZ0E5Y15PZIACT
METHYL SALICYLATELAV5U5022YACTIB
TROLAMINE9O3K93S3TKIACT
EUCALYPTUS OIL2R04ONI662IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
32025-12-04monthly-update2026-06-03 17:45:23

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
FlexSport Roll OnMETHYL SALICYLATEPharmadel LLCbf8de3da-7628-6112-e053-2995a90a8e162026-03-26WarningsExact identifier
ndc (package): 55758-360-03
ndc (product): 55758-360
ndc11 (package): 55758036003
spl id: 4df1790a-7a08-143f-e063-6394a90abec7
spl set id: bf8de3da-7628-6112-e053-2995a90a8e16

Reported adverse events (FAERS/openFDA)#

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