Your browser does not support JavaScript! SUNMARK ANTIFUNGAL (TOLNAFTATE) CREAM [MCKESSON]
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RxNorm Names

SUNMARK ANTIFUNGAL (tolnaftate) cream
[McKesson]


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

  • clinically proven to cure most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis)
  • helps prevent most athlete's foot from recurring when used daily
  • effectively soothes and relieves symptoms of athlete's foot, including itching, burning and cracking

Warnings

For external use only

When using this product avoid contact with the eyes

Stop use and ask a doctor if

  • irritation occurs
  • there is no improvement within 4 weeks (for athlete's foot or ringworm) or within 2 weeks (for jock itch)

Do not use on children under 2 years of age except under the advice and supervision of a doctor.

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
  • this product is not effective on scalp or nails

For athlete's foot

  • pay special attention to spaces between toes
  • wear well-fitting shoes, 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

Other information

  • Store between 15° - 30°C (59° - 86°F)
  • See end panel of carton and tube crimp for lot number and expiration date

Inactive ingredients

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

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

sunmark™

antifungal cream

Tolnaftate 1%
CURES & PREVENTS MOST ATHLETE'S FOOT

NET WT 0.5 OZ (15 g)

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton
SUNMARK   ANTIFUNGAL
tolnaftate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-155
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 Description
1NDC:49348-155-291 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH FINALpart333C02/17/2006
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-155)

Revised: 02/2013
Document Id: 155ba245-491d-4a85-be99-f49786e61cd9
Set id: d0c30c74-9472-4978-9623-8c7dbeb99411
Version: 1
Effective Time: 20130206
 
McKesson

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