SUNMARK  ANTIFUNGAL- tolnaftate cream 
McKesson

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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sunmark
antifungal

Drug Facts

Active ingredient

Tolnaftate 1%

Purpose

Antifungal

Uses

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

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

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 Type HUMAN OTC DRUG Item Code (Source) NDC:49348-155
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:49348-155-29 1 in 1 CARTON
1 15 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 - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-155)

Revised: 2/2013
Document Id: 155ba245-491d-4a85-be99-f49786e61cd9
Set id: d0c30c74-9472-4978-9623-8c7dbeb99411
Version: 1
Effective Time: 20130206
 
McKesson