OTC Medication Information: Flexitol Foot and Knee Pain Relief

FLEXITOL FOOT AND KNEE PAIN RELIEF- methyl salicylate gel
LaCorium Health USA Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Facts

Active ingredient

Methyl Salicylate10%

Purpose

Topical analgesic

Uses

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

  • strains
  • bruises
  • sprains
  • arthritis

Warnings

For external use only

Stop use and ask a doctor if

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

When using this product

  • 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

Do not use on broken skin

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

Directions

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

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

Inactive ingredients

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?

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

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

PRINCIPAL DISPLAY PANEL — 56 g Tube Carton

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
(click image for full-size original)
FLEXITOL FOOT AND KNEE PAIN RELIEF
methyl salicylate gel
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:43251-2400
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Methyl Salicylate (SALICYLIC ACID) Methyl Salicylate 100 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL
Alcohol
C13-14 Isoparaffin
Laureth-7
Arnica Montana Flower
Peppermint oil
Benzyl alcohol
Tocopherol
POLYACRYLAMIDE (1300000 MW)
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:43251-2400-1 1 TUBE in 1 CARTON contains a TUBE
1 56 g in 1 TUBE This package is contained within the CARTON (43251-2400-1)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part348 01/01/2022
Labeler — LaCorium Health USA Inc. (111254392)
Establishment
Name Address ID/FEI Operations
Ross Laboratories Aust Pty Ltd 753529114 MANUFACTURE (43251-2400), LABEL (43251-2400), ANALYSIS (43251-2400), PACK (43251-2400)

Revised: 06/2022 LaCorium Health USA Inc.

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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