TOPCARE  TOLNAFTATE ANTIFUNGAL- tolnaftate cream 
Topco Associates LLC

Disclaimer: 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.

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TopCare®
Tolnaftate Antifungal Cream

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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.

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:36800-052
Route of Administration TOPICAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Tolnaftate (UNII: 06KB629TKV) (Tolnaftate - UNII:06KB629TKV) Tolnaftate 10 mg  in 1 g
Inactive Ingredients
Ingredient Name Strength
Butylated Hydroxytoluene (UNII: 1P9D0Z171K)  
Polyethylene glycol 400 (UNII: B697894SGQ)  
Polyethylene glycol 3350 (UNII: G2M7P15E5P)  
titanium dioxide (UNII: 15FIX9V2JP)  
petrolatum (UNII: 4T6H12BN9U)  
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:36800-052-60 1 in 1 CARTON
1 14.2 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH FINAL part333C 02/17/2006
Labeler - Topco Associates LLC (006935977)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(36800-052)

Revised: 1/2013
Document Id: fc414094-dab4-410e-9cab-486986e783d4
Set id: aba4ce9a-ae88-4223-b20f-d7897f7c2232
Version: 1
Effective Time: 20130110
 
Topco Associates LLC