FLEXITOL FOOT AND KNEE PAIN RELIEF- methyl salicylate gel

Flexitol Foot and Knee Pain Relief by

Drug Labeling and Warnings

Flexitol Foot and Knee Pain Relief by is a Otc medication manufactured, distributed, or labeled by LaCorium Health USA Inc., Ross Laboratories Aust Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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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

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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

INGREDIENTS AND APPEARANCE

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

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Methyl Salicylate (UNII: LAV5U5022Y) (SALICYLIC ACID - UNII:O414PZ4LPZ)	Methyl Salicylate	100 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
POLYOXYL 40 HYDROGENATED CASTOR OIL (UNII: 7YC686GQ8F)
Alcohol (UNII: 3K9958V90M)
C13-14 Isoparaffin (UNII: E4F12ROE70)
Laureth-7 (UNII: Z95S6G8201)
Arnica Montana Flower (UNII: OZ0E5Y15PZ)
Peppermint oil (UNII: AV092KU4JH)
Benzyl alcohol (UNII: LKG8494WBH)
Tocopherol (UNII: R0ZB2556P8)
POLYACRYLAMIDE (1300000 MW) (UNII: SC5Y4X78TG)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-2400-1	1 in 1 CARTON	01/01/2022	12/31/2024
1		56 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M017	01/01/2022	12/31/2024

Labeler - LaCorium Health USA Inc. (111254392)

Establishment
Name	Address	ID/FEI	Business Operations
Ross Laboratories Aust Pty Ltd		753529114	MANUFACTURE(43251-2400) , LABEL(43251-2400) , ANALYSIS(43251-2400) , PACK(43251-2400)