FDA.reportPublic FDA data

FlexSport Roll On

Manufacturer
Pharmadel LLC
Effective date
2021-04-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:47:34

Label at a glance#

ProductFlexSport Roll On
Active ingredientMENTHOL
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 2 years: apply to affected area not more than 3 to 4 times daily children under 2 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 2 years: apply to affected area not more than 3 to 4 times daily
  • children under 2 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
  • Do not use if clear shrink seal over cap is broken, torn or missing.
  • save box for complete drug facts

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 Cream

FlexSport

Pain Relief

ROLL-ON

  • Muscle & Joint Pain
  • Backaches
  • Arthritis

2.5 fl oz (74 mL)

FlexSport RollonFlexSport Rollon

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
55758-316-022021-04-09C16284748780-1ba0f9c33-521c-a910-e053-dadaa90a0b85FlexSport Roll On
55758-316-022021-01-29C16284748780-1ba0f9c33-521c-a910-e053-dadaa90a0b85FlexSport Roll On

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55758-31655758-316-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CARBOMER INTERPOLYMER TYPE A (ALLYL SUCROSE CROSSLINKED)59TL3WG5COIACT
DIHYDROCAPSAICINW9BV32M08AIACT
MENTHOLL7T10EIP3AACTIB
TROLAMINE9O3K93S3TKIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
ISOPROPYL MYRISTATE0RE8K4LNJSIACT

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
bf8edfa4-fe84-29ee-e053-2995a90aa8fe85b8ef3d-72fa-7f3b-e053-2991aa0a07772021-04-09WarningsExact identifier
spl id: bf8edfa4-fe84-29ee-e053-2995a90aa8fe
spl set id: 85b8ef3d-72fa-7f3b-e053-2991aa0a0777

Reported adverse events (FAERS/openFDA)#

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