Rugby Antifungal Clotrimazole Cream
FDA Label NDC 71205-738

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Proficient Rx Lp for the product Rugby Antifungal Clotrimazole (NDC 71205-738). 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, stop use and ask a doctor if, otc - pregnancy or breast feeding, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

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Drug Facts

Distributed by:
RUGBY® LABORATORIES
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152

Relabeled by:
PROFICIENT RX LP
Thousand Oaks, CA 91320

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • ▪cures most athlete's foot, jock itch, and ringworm
  • ▪relieves itching, burning, cracking, scaling and discomfort

Warnings

For external use only.

Avoid contact with eyes.

Otc - Do Not Use

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

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - Keep Out Of Reach Of Children

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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 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 daily
  • ▪for athlete's foot and ringworm, use daily for 4 weeks; for jock itch, use daily for 2 weeks
  • ▪if condition persists longer, consult a doctor
  • ▪this product is not effective on scalp or nails

Other Information

  • ▪store at 15 to 30°C (59 to 86°F)
  • ▪Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive Ingredients

aloe barbadensis leaf juice, carbomer, cetyl alcohol, DMDM hydantoin, glyceryl stearate, isopropyl alcohol, methylparaben, mineral oil, polysorbate-20, propylparaben, purified water, stearic acid, triethanolamine, trisodium EDTA

Questions Or Comments?

1-800-645-2158

Principal Display Panel - 14 G Tube Carton

NDC 71205-738-15

Compare to the
active ingredient
of Lotrimin® AF*

Antifungal Cream
Clotrimazole 1%

Cures most athlete's foot

NET WT 0.5 OZ (14 g)

71205-738-15 (Rugby 01)

71205-738-15 (Rugby 01)

* Please review the disclaimer below.