Your browser does not support JavaScript! TOPCARE TOLNAFTATE ANTIFUNGAL (TOLNAFTATE) CREAM [TOPCO ASSOCIATES LLC]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

TOPCARE TOLNAFTATE ANTIFUNGAL (tolnaftate) cream
[Topco Associates LLC]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph final
NOTE:MOST OTC DRUGS ARE NOT REVIEWED AND APPROVED BY FDA, HOWEVER THEY MAY BE MARKETED IF THEY COMPLY WITH APPLICABLE REGULATIONS AND POLICIES. FDA HAS NOT EVALUATED WHETHER THIS PRODUCT COMPLIES.
Drug Label Sections

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis), jock itch (tinea cruris), and ringworm (tinea corporis)
  • helps prevent most athlete's foot with daily use
  • for effective relief of
    • itching
    • scaling
    • cracking
    • burning
    • redness
    • soreness
    • irritation
    • discomfort

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 within 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 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 controlled room temperature
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

BHT, PEG-400, PEG-3350, titanium dioxide, white petrolatum

QUESTIONS?

1-888-423-0139
topcare@topco.com

DISTRIBUTED BY
TOPCO ASSOCIATES LLC
7711 GROSS POINT RD
SKOKIE, IL 60077

PRINCIPAL DISPLAY PANEL - 14.2 g Tube Carton

TopCare®

CURES AND PREVENTS MOST ATHLETE'S FOOT

Antifungal Cream

TOLNAFTATE 1% CREAM

QUALITY
GUARANTEED

COMPARE TO
TINACTIN®
active ingredient*

NET WT 0.5 OZ (14.2 g)

Principal Display Panel - 14.2 g Tube Carton
TOPCARE   TOLNAFTATE ANTIFUNGAL
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:36800-052
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Tolnaftate (Tolnaftate) Tolnaftate10 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxytoluene 
Polyethylene glycol 400 
Polyethylene glycol 3350 
titanium dioxide 
petrolatum 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:36800-052-601 in 1 CARTON
114.2 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C02/17/2006
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(36800-052)

Revised: 1/2013
 
Topco Associates LLC

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services