Clotrimazole Solution
FDA Label NDC 10135-671

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Marlex Pharmaceuticals Inc for the product Clotrimazole (NDC 10135-671). 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 active ingredient, purpose, uses, warnings, ask a doctor before use, when using this product, stop use and ask a doctor if, keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

Cures most

  • Athlete's foot (tinea pedis)
  • Jock Itch (tinea cruris)
  • Ringworm (tinea corporis)

    • Effectively relieves

    • Itching
    • Cracking
    • Burning

      • Discomfort which can accompany these conditions

Warnings

For external use only

Ask A Doctor Before Use

on children under 2 years of age

When Using This Product

avoid contact with eyes

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)

Keep Out Of Reach Of Children

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

Directions

  • This product is not effective on the scalp or nails For best results, follow directions and continue treatment for length of time indicated. For athlete's foot and ringworm: use daily for 4 weeks. For jock itch: use daily for 2 weeks.
  • clean the affected area and dry thoroughly
  • apply a thin layer of the product 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; change shoes and socks at least once daily

Other Information

  • Store at 15° to 30°C (59° to 86°F)

Inactive Ingredient

polyethylene glycol 400

Principal Display Panel - 10 Ml Bottle Carton

NDC 10135-0671-81

Compare to the active ingredient of Lotrimin® AF*

Clotrimazole Topical Solution USP,1%

Antifungal

  • Relieves Itching & Burning
  • Greaseless, Nonstaining

    • For External use only.

    Not for Opthalmic use.

    Keep this and all medications out of the reach of children.

    Marlex Pharmaceuticals, Inc.

    10mL

    Principal Display Panel (10 mL Bottle CartonNDC 10135-0671-81Compare to the active ingredient of Lotrimin® AF* Clotrimazole Topical Solution USP,1% AntifungalRelieves Itching & Burning Greaseless, NonstainingFor External use only. Not for Opthalmic use.Keep this and all medications out of the reach of children. Marlex Pharmaceuticals, Inc.10mL)

    Principal Display Panel (10 mL Bottle CartonNDC 10135-0671-81Compare to the active ingredient of Lotrimin® AF* Clotrimazole Topical Solution USP,1% AntifungalRelieves Itching & Burning Greaseless, NonstainingFor External use only. Not for Opthalmic use.Keep this and all medications out of the reach of children. Marlex Pharmaceuticals, Inc.10mL)

* Please review the disclaimer below.