Clotrimazole
FDA Label NDC 51852-103

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Lifelabs, A Division Of Atico International Usa, Inc. for the product Clotrimazole (NDC 51852-103). 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 clotrimazole, otc - purpose, warnings, indications & usage, otc - stop use, otc - keep out of reach of children, dosage & administration, storage and handling, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Clotrimazole

Active Ingredient

Clotrimazole 1%

Otc - Purpose

Purpose

Antifungal

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.

Indications & Usage

When using this product avoid contact with the eyes.

Otc - Stop Use

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

Dosage & Administration

Directions

  • 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 conditions persist longer, ask a doctor
  • this product is not effective on the scalp or nails

Storage And Handling

Other information

store between 2o and 30o C (30o and 86o F) Lot No. and Exp. Date: see box or see crimp of tube

Inactive Ingredient

Inactive ingredients

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

Otc - Questions

Questions?

Call 1-800-645-3867, Mon-Fri 8:30 AM - 5:30 PM.

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