Clotrimazole Solution
FDA Label NDC 0536-1443

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rugby Laboratories, Inc. for the product Clotrimazole (NDC 0536-1443). 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, ask a doctor before use, when using this product, 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

Distributed by:
RUGBY ®LABORATORIES
Indianapolis, IN 46268

Active Ingredient

Clotrimazole USP, 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and 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)

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

  • 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 20° to 25°C (68° to 77°F)[see USP Controlled Room Temperature].

Inactive Ingredients

polyethylene glycol 400

Questions?

Call 1-866-923-4914

Principal Display Panel - 10 Ml Bottle Carton

Rugby ®

NDC 0536-1443-70
Compare to the
active ingredient in
Lotrimin ®AF*
Clotrimazole Antifungal

Clotrimazole
Topical Solution
USP, 1%
Antifungal

Cures Most
Athlete's Foot

  • Relieves Itching, Burning
  • Greaseless, Nonstaining

    • 10 mL (⅓ fl oz)

    Principal Display Panel (10 mL Bottle Carton)

    Principal Display Panel (10 mL Bottle Carton)

* Please review the disclaimer below.