Flexitol Medicated Foot Cream

Flexitol Medicated Foot Cream
SPL v1
SPL
SPL Set ID c31da255-e671-41e3-8607-efbb6973163c
Route
TOPICAL
Published
Effective Date 2012-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Urea Cetostearyl Alcohol Mineral Oil Glycerin Propylene Glycol Petrolatum Polysorbate 60 Ceteth-20 Cetyl Alcohol Menthol Sodium Phosphate Benzalkonium Chloride Tocopherol Lavender Oil Aloe Vera Leaf Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2012-08-11

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

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.
Section 42229-5

Drug Facts

Section 50565-1
  • Do not use if seal on tube is punctured or is not visible. Keep out of reach of children.
Section 50566-9
  • If irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot) discontinue use and consult a doctor
Section 50567-7
  • For External Use Only
  • Avoid contact with eyes
Section 50570-1
  • Do not use on children under 2 years of age unless directed by a doctor
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.
Active Ingredient

Tolnaftate 1%

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

[email protected]

www.flexitol.com

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)


Structured Label Content

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.
Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Do not use if seal on tube is punctured or is not visible. Keep out of reach of children.
Section 50566-9 (50566-9)
  • If irritation occurs or if there is no improvement within 4 weeks (for Athlete's Foot) discontinue use and consult a doctor
Section 50567-7 (50567-7)
  • For External Use Only
  • Avoid contact with eyes
Section 50570-1 (50570-1)
  • Do not use on children under 2 years of age unless directed by a doctor
Purpose

Antifungal

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.
Active Ingredient

Tolnaftate 1%

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? (Questions or comments?)

Call Toll Free 1-866-478-3338

[email protected]

www.flexitol.com

Principal Display Panel 56 G Tube Carton (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)


Advanced Ingredient Data


Raw Label Data

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