Kerasal ®

Kerasal ®
SPL v4
SPL
SPL Set ID 54a7bebf-d7f2-414d-8f1a-8669ddefaa8b
Route
TOPICAL
Published
Effective Date 2022-03-15
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Tolnaftate (1 g)
Inactive Ingredients
Aloe Vera Leaf .alpha.-tocopherol Acetate Ceramide Ng Dimethicone Dimethicone Crosspolymer (450000 Mpa.s At 12% In Cyclopentasiloxane) Eucalyptus Oil Isododecane Peppermint Oil Tea Tree Oil

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-28 Until 2026-06-30

Description

Drug Facts

Purpose

Antifungal


Medication Information

Purpose

Antifungal

Description

Drug Facts

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis)
  • clinically proven to prevent most Athlete's Foot with daily use
  • for effective relief of itching, cracking, burning, scaling and discomfort
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 50567-7

When using this productavoid contact with the eyes.

Section 50570-1

Do not useon children under 2 years of age unless directed by a doctor.

Warnings

For external use only

Directions
  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • pay special attention to 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, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
  • this product is not effective on the scalp or nails
Questions?

1-877-674-3475

www.Kerasal.com

Active Ingredient

Tolnaftate 1%

Other Information

Store between 20-25°C (68-77°F)

Inactive Ingredients

aloe vera leaf, alpha tocopheryl acetate, ceramide NG, dimethicone, dimethicone crosspolymer, eucalyptus oil, isododecane, peppermint oil, tea tree oil

Stop Use and Ask A Doctor If
  • irritation occurs
  • there is no improvement within 4 weeks.
Principal Display Panel 12 G Tube Carton

NEW

Tolnaftate Antifungal

Kerasal ®

For Athlete's Foot

Silky Clear Gel

5 IN 1™

CURES

Most Athlete s Foot

PREVENTS

Recurrence

RELIEVES

Itching, Burning And Scaling

NOURISHES

Improves Skin Appearance

DEODORIZES

With Essential Oils

Enriched with Natural Tea Tree Oil,

Aloe, Ceramides & Vitamin E

NET WT 0.42 oz (12 g)


Structured Label Content

Uses
  • proven clinically effective in the treatment of most athlete's foot (tinea pedis)
  • clinically proven to prevent most Athlete's Foot with daily use
  • for effective relief of itching, cracking, burning, scaling and discomfort
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 50567-7 (50567-7)

When using this productavoid contact with the eyes.

Section 50570-1 (50570-1)

Do not useon children under 2 years of age unless directed by a doctor.

Purpose

Antifungal

Warnings

For external use only

Directions
  • wash the affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • supervise children in the use of this product
  • pay special attention to 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, ask a doctor
  • to prevent athlete's foot, apply once or twice daily (morning and/or night, or as directed by a doctor)
  • this product is not effective on the scalp or nails
Questions?

1-877-674-3475

www.Kerasal.com

Active Ingredient (Active ingredient)

Tolnaftate 1%

Other Information (Other information)

Store between 20-25°C (68-77°F)

Inactive Ingredients (Inactive ingredients)

aloe vera leaf, alpha tocopheryl acetate, ceramide NG, dimethicone, dimethicone crosspolymer, eucalyptus oil, isododecane, peppermint oil, tea tree oil

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • irritation occurs
  • there is no improvement within 4 weeks.
Principal Display Panel 12 G Tube Carton (PRINCIPAL DISPLAY PANEL - 12 g Tube Carton)

NEW

Tolnaftate Antifungal

Kerasal ®

For Athlete's Foot

Silky Clear Gel

5 IN 1™

CURES

Most Athlete s Foot

PREVENTS

Recurrence

RELIEVES

Itching, Burning And Scaling

NOURISHES

Improves Skin Appearance

DEODORIZES

With Essential Oils

Enriched with Natural Tea Tree Oil,

Aloe, Ceramides & Vitamin E

NET WT 0.42 oz (12 g)


Advanced Ingredient Data


Raw Label Data

All Sections (JSON)