Zapotol Clotrimazole
FDA Label NDC 59428-359

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Zapotol Corp. for the product Zapotol Clotrimazole (NDC 59428-359). 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 otc - active ingredient, otc - purpose, warnings, otc - when using, otc - ask doctor, otc - keep out of reach of children, indications & usage, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Active Ingredient

Active ingredient                                                         Purpose

Clotrimazole 1%--------------------------------------------- Antifungal

Otc - Purpose

Uses

  • Cures most athlete's foot, jock itch, and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

Warnings

Do not use on children under 2 years of age except under the advice and supervision of a doctor

For external use only

Otc - When Using

When using this product avoid contact with the eyes

Otc - Ask Doctor

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot and ringworm) or 2 weeks (for jock itch)
  • do not use for diaper rash

Otc - Keep Out Of Reach Of Children

Keep out of reach of childern

If swallowed, get medical help or contact a Poison Control Center right away.

Indications & Usage

Direction

  • Wash affected area and dry thoroughly
  • Apply a thin layer over 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 spaces between the toes, wear well fitting ventilated shoes and change shoes and socks at least once a day
  • For athlete's foot and ringworm use daily for 4 weeks, for jock itch use daily for 2 weeks
  • If condition persists longer, ask a doctor
  • This product is not effective on the scalp or nails

Storage And Handling

Other information

Lot No. & Exp. Date;see box or see crimp of the tube

Store between 20°C to 25°C (68°F to 77°F)

Inactive Ingredient

Inactive ingredients

benzyl alcohol, isopropyl myristate, liquid paraffin, polysorbate 60, propylene glycol, purified water, sorbitan monostearate, stearic acid, stearyl alcohol

Dosage & Administration

DISTRIBUTED BY:

PRODUCTOS ZAPOTOL CORP.

Van Nuys, CA 91402

888-927-6865

Made in Korea

Package Label.Principal Display Panel

Image Description (1350.1)

Image Description (1350.1)

* Please review the disclaimer below.