FDA.reportPublic FDA data

Flexitol ® Foot & Knee Pain Relief Gel

Manufacturer
LaCorium Health USA Inc. | Ross Laboratories Aust Pty Ltd
Effective date
2024-09-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:53:24

Label at a glance#

ProductFlexitol Foot and Knee Pain Relief
Active ingredientMethyl Salicylate
Label structure11 sections

Indications and uses

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

Dosage and administration

Adults and children 2 years of age and older: apply to affected area not more than 3 - 4 times daily Children under 2 years of age: consult a physician

Storage and handling

Store between 50-86˚F in a dry place Do not use if tube seal is broken or appears tampered with

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Methyl Salicylate10%

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:

  • strains
  • bruises
  • sprains
  • arthritis

Warnings

WARNINGS SECTION

For external use only

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

When using this product

OTC - WHEN USING SECTION

  • do not get into eyes
  • if contact occurs, rinse eyes thoroughly with water
  • do not use on broken skin
  • do not bandage tightly
  • do not use other than as directed

OTC - DO NOT USE SECTION

Do not use on broken skin

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 and older:

  • apply to affected area not more than 3 - 4 times daily

Children under 2 years of age:

  • consult a physician

Other Information

STORAGE AND HANDLING SECTION

  • Store between 50-86˚F in a dry place
  • Do not use if tube seal is broken or appears tampered with

Inactive ingredients

INACTIVE INGREDIENT SECTION

arnica montana flower extract, benzyl alcohol, C13-14 isoparaffin, ethanol, laureth-7, PEG-40 hydrogenated castor oil, peppermint oil, polyacrylamide, tocopherol, water

Questions or Comments?

OTC - QUESTIONS SECTION

Call Toll Free 1-866-478-3338
usainfo@flexitol.com
www.flexitol.com

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY:
LaCorium Health USA Inc
801 Broad St, Suite 600
Chattanooga, TN 37402

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC: 43251-2400-1

Flexitol®

FOOT
& KNEE
PAIN
RELIEF GEL

PAIN RELIEF

FOR FOOT & KNEE PAIN
ASSOCIATED WITH:

  • STRAINS
  • BRUISES
  • SPRAINS
  • ARTHRITIS

NON-GREASY,
QUICK ABSORBING

WITH METHYL
SALICYLATE 10%

TOPICAL
ANALGESIC

AUSTRALIAN
MADE & OWNED

Net Wt. 2 oz (56 g) GEL

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton
PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43251-240043251-2400-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
Methyl SalicylateLAV5U5022YACTIB
POLYOXYL 40 HYDROGENATED CASTOR OIL7YC686GQ8FIACT
Alcohol3K9958V90MIACT
C13-14 IsoparaffinE4F12ROE70IACT
Laureth-7Z95S6G8201IACT
Arnica Montana FlowerOZ0E5Y15PZIACT
Peppermint oilAV092KU4JHIACT
Benzyl alcoholLKG8494WBHIACT
TocopherolR0ZB2556P8IACT
POLYACRYLAMIDE (1300000 MW)SC5Y4X78TGIACT

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
50189e4a-0bcf-4e0b-bb37-c6c090f99c553079e7e6-bb74-4a7a-92dc-bf8c5374332b2024-09-27WarningsExact identifier
spl id: 50189e4a-0bcf-4e0b-bb37-c6c090f99c55
spl set id: 3079e7e6-bb74-4a7a-92dc-bf8c5374332b

Reported adverse events (FAERS/openFDA)#

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