FLEXITOL MEDICATED FOOT- tolnaftate cream

Flexitol Medicated Foot by

Drug Labeling and Warnings

Flexitol Medicated Foot by is a Otc medication manufactured, distributed, or labeled by LaCorium Health International Pty Ltd, Jalco Pharmaceuticals Pty Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

• Clinically proven to prevent Athlete's Foot (Tinea Pedis) and Ringworm (Tinea Corporis) with daily use
• For effective relief of symptoms of Athlete's Foot, including itching, burning, cracking, scaling and discomfort associated with this condition.

Warnings

• Do not use on children under 2 years of age unless directed by a doctor

• For External Use Only
• Avoid contact with eyes

• If irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot) discontinue use and consult a doctor

• Do not use if seal on tube is punctured or is not visible. Keep out of reach of children.

Directions

• Clean the affected area and dry thoroughly
• Apply a thin layer of the product over the affected area twice daily (morning and night), or as directed by a doctor
• Supervise children in the use of this product
• For Athlete's Foot: pay special attention to the spaces between the toes; wear well fitting, ventilated shoes and change shoes and socks at least once daily.
• Use daily for 4 weeks. If condition persists longer consult a doctor.
• To prevent Athlete's Foot, apply once or twice daily (morning and/or night)
• This product is not effective on the scalp or nails
• Replace cap and tighten after each use.

Other Information

• Store between 50°- 86°F in a dry place

Inactive Ingredients

Aloe, Benzalkonium Chloride, Cetearyl Alcohol, Ceteth-20, Cetyl Alcohol, Glycerin, Lavandula, Angustifolia (Lavender) Oil, Menthol, Mineral Oil, Petrolatum, Polysorbate 60, Propylene Glycol, Sodium Phosphate, Tocopherol, Urea, Water

Questions or comments?

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

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USA DISTRIBUTOR:
LaCorium Health USA Inc.,
Boca Raton, Florida 33487

MANUFACTURED FOR:
LaCorium Health International Pty Ltd.,
Level 14, Tower 2,
101 Grafton Street,
Bondi Junction NSW 2022, Australia

PRINCIPAL DISPLAY PANEL - 56 g Tube Carton

Flexitol®

Medicated
Foot Cream

For treatment of
athlete's foot

Before

After 2 Weeks

APPROVED

AMERICAN
PODIATRIC
MEDICAL
ASSOCIATION

With Aloe & Vitamin E

DIABETIC FRIENDLY

Net Wt 2 oz (56 g)

INGREDIENTS AND APPEARANCE

FLEXITOL MEDICATED FOOT 
tolnaftate cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 43251-3340
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV)	Tolnaftate	1 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
Urea (UNII: 8W8T17847W)
Cetostearyl Alcohol (UNII: 2DMT128M1S)
Mineral Oil (UNII: T5L8T28FGP)
Glycerin (UNII: PDC6A3C0OX)
Propylene glycol (UNII: 6DC9Q167V3)
Petrolatum (UNII: 4T6H12BN9U)
Polysorbate 60 (UNII: CAL22UVI4M)
Ceteth-20 (UNII: I835H2IHHX)
Cetyl alcohol (UNII: 936JST6JCN)
Menthol (UNII: L7T10EIP3A)
Sodium phosphate (UNII: SE337SVY37)
Benzalkonium chloride (UNII: F5UM2KM3W7)
Tocopherol (UNII: R0ZB2556P8)
Lavender Oil (UNII: ZBP1YXW0H8)
Aloe Vera Leaf (UNII: ZY81Z83H0X)
Water (UNII: 059QF0KO0R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 43251-3340-1	1 in 1 CARTON
1		56 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part333C	08/11/2012

Labeler - LaCorium Health International Pty Ltd (758651624)

Establishment
Name	Address	ID/FEI	Business Operations
Jalco Pharmaceuticals Pty Ltd		757701409	MANUFACTURE(43251-3340) , PACK(43251-3340) , LABEL(43251-3340) , ANALYSIS(43251-3340)