Topcare
FDA Label NDC 36800-052

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare (NDC 36800-052). 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, otc - do not use, stop use and ask a doctor if, otc - pregnancy or breast feeding, otc - 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

Other

Drug Facts

For external use only.

Avoid contact with eyes.

DISTRIBUTED BY TOPCO ASSOCIATES LLC
ELK GROVE VILLAGE, IL 60007

Active Ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

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 of breastfeeding, 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 right away: 800-222-1222.

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 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 the 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

ceteth-20, cetyl alcohol, chlorocresol, mineral oil, monobasic sodium phosphate, petrolatum, propylene glycol, purified water, stearyl alcohol

Questions Or Comments?

866-323-0107 or www.natureplex.com

Principal Display Panel - 14 G Tube Carton

NDC 36800-052-60

TopCare
health™

PRESCRIPTION STRENGTH

Athlete's Foot Cream

TOLNAFTATE CREAM 1% • ANTIFUNGAL

• OUR PHARMACISTS •
RECOMMEND

NET WT 0.5 OZ (14 g)

Principal Display Panel (14 g Tube Carton)

Principal Display Panel (14 g Tube Carton)

* Please review the disclaimer below.