Topcare Cream
FDA Label NDC 36800-495

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 36800-495). 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, otc - when using, 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
TOPCO ASSOCIATES LLC
7711 GROSS POINT ROAD
SKOKIE, IL 60077

Active Ingredient

Clotrimazole 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot, jock itch and ringworm
  • relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Warnings

For external use only

Otc - Do Not Use

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

Otc - When Using

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 or 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

  • wash affected area and dry thoroughly
  • apply a thin layer over affected area twice daily (morning and night)
  • 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 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, ask a doctor
  • this product is not effective on the scalp or nails

Other Information

  • To open: unscrew cap, use the pointed end of cap to puncture seal.
  • store between 20°- 25°C (68° - 77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive Ingredients

benzyl alcohol (1%), cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sorbitan monostearate

Principal Display Panel - 14.2 G Tube Carton

TopCare®

CURES MOST ATHLETE'S FOOT

Antifungal Cream

CLOTRIMAZOLE CREAM USP, 1%

QUALITY
GUARANTEED

COMPARE TO
LOTRIMIN® AF
active ingredient*

NET WT 0.5 OZ (14.2 g)

Principal Display Panel (14.2 g Tube Carton)

Principal Display Panel (14.2 g Tube Carton)

* Please review the disclaimer below.