Kerasal For Athletes Foot Silky Clear Gel
FDA Label NDC 16864-100

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Advantice Health, Llc for the product Kerasal For Athletes Foot Silky Clear (NDC 16864-100). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, uses, warnings, otc - do not use, otc - when using, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

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

Warnings

For external use only

Otc - Do Not Use

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

Otc - When Using

When using this product avoid contact with the eyes.

Stop Use And Ask A Doctor If

  • irritation occurs
  • there is no improvement within 4 weeks.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

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

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

Questions?

1-877-674-3475
www.Kerasal.com

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)

Principal Display Panel (12 g Tube Carton)

Principal Display Panel (12 g Tube Carton)

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