Flexitol®

Flexitol®
SPL v3
SPL
SPL Set ID 39f54d88-4e35-4f26-a988-42807d7e010e
Route
TOPICAL
Published
Effective Date 2012-12-20
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Undecylenic Acid (250 mg)
Inactive Ingredients
Isopropyl Alcohol Water Urea Eucalyptus Oil Hypromellose 2906 (4000 Mpa.s) Tea Tree Oil .alpha.-tocopherol Acetate, Dl- Aloe Vera Leaf Butylated Hydroxytoluene

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2009-01-03

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses

For the treatment of: most Athlete's Foot (Tinea Pedis), Ringworm (Tinea Corporis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation and discomfort which may accompany these conditions.

Section 42229-5

Drug Facts

Section 50565-1
  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9
  • Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks
Section 50567-7
  • Extremely flammable
  • Keep away from fire or flame
  • Avoid smoking during use and until product has dried
Section 50570-1
  • Do not use on children under 2 years of age unless directed by a doctor
Warnings
  • For external use only
Directions
  • Read all directions and warnings before use
  • Clean affected area with soap and warm water and dry thoroughly
  • Apply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor
  • 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.
  • For Athlete's Foot and Ringworm use daily for 4 weeks. If condition persists longer, consult a doctor.
  • Persons under 18 years of age or those with sensitive skin should use only as directed by a doctor
  • Supervise children in the use of this product
  • This product is not effective on the scalp or nails
  • Replace cap and tighten after each use
Active Ingredient

Undecylenic Acid 25%

Other Information

Store between 50° – 86°F in a dry place

Inactive Ingredients

Aloe Barbadensis Leaf Juice, Butylated Hydroxytoluebe, Eucalyptus Globulus Oil, Hydroxypropyl Methylcellulose, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol Acetate, Urea, Water

Comments Or Questions?

Call Toll Free 1-866-478-3338

[email protected]

www.flexitol.com

Principal Display Panel 30ml Bottle Carton

Flexitol ®

Anti-Fungal

Liquid

Treats Fungus

APPROVED

AMERICAN

PODIATRIC

MEDICAL

ASSOCIATION

Clinically Proven

Easy brush-on APPLICATOR

WITH UREA, ALOE VERA, VITAMIN E,

TEA TREE & EUCALYPTUS OILS

NDC: 43251-3351

1 fl oz (30ml)


Structured Label Content

Uses

For the treatment of: most Athlete's Foot (Tinea Pedis), Ringworm (Tinea Corporis). For relief of: itching, scaling, cracking, burning, redness, soreness, irritation and discomfort which may accompany these conditions.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)
  • Keep out of reach of children
  • If swallowed, get medical help or contact a Poison Control Center right away
Section 50566-9 (50566-9)
  • Discontinue use and consult a doctor if irritation occurs or there is no improvement within 4 weeks
Section 50567-7 (50567-7)
  • Extremely flammable
  • Keep away from fire or flame
  • Avoid smoking during use and until product has dried
Section 50570-1 (50570-1)
  • Do not use on children under 2 years of age unless directed by a doctor
Purpose

Antifungal

Warnings
  • For external use only
Directions
  • Read all directions and warnings before use
  • Clean affected area with soap and warm water and dry thoroughly
  • Apply a thin layer of Flexitol Anti-Fungal Liquid over the affected area twice daily (morning and night) or as directed by a doctor
  • 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.
  • For Athlete's Foot and Ringworm use daily for 4 weeks. If condition persists longer, consult a doctor.
  • Persons under 18 years of age or those with sensitive skin should use only as directed by a doctor
  • Supervise children in the use of this product
  • This product is not effective on the scalp or nails
  • Replace cap and tighten after each use
Active Ingredient (Active ingredient)

Undecylenic Acid 25%

Other Information (Other information)

Store between 50° – 86°F in a dry place

Inactive Ingredients (Inactive ingredients)

Aloe Barbadensis Leaf Juice, Butylated Hydroxytoluebe, Eucalyptus Globulus Oil, Hydroxypropyl Methylcellulose, Isopropyl Alcohol, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Tocopherol Acetate, Urea, Water

Comments Or Questions? (Comments or questions?)

Call Toll Free 1-866-478-3338

[email protected]

www.flexitol.com

Principal Display Panel 30ml Bottle Carton (PRINCIPAL DISPLAY PANEL - 30ml Bottle Carton)

Flexitol ®

Anti-Fungal

Liquid

Treats Fungus

APPROVED

AMERICAN

PODIATRIC

MEDICAL

ASSOCIATION

Clinically Proven

Easy brush-on APPLICATOR

WITH UREA, ALOE VERA, VITAMIN E,

TEA TREE & EUCALYPTUS OILS

NDC: 43251-3351

1 fl oz (30ml)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)