ATHLETES FOOT- terbinafine hydrochloride cream 
McKesson

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Athlete's Foot Cream

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

Warnings

For external use only

Do not use

  • on nails or scalp
  • in or near the mouth or the eyes
  • for vaginal yeast infections

When using this product do not get into the eyes. If eye contact occurs, rinse thoroughly with water.

Stop use and ask a doctor if

  • too much irritation occurs or gets worse.
  • side effects occur. You may report side effects to FDA at 1-800-FDA-1088.

Keep out of reach of children. If swallowed, get medical help or contact a poison control center right away.

Directions

  • adults and children 12 years and older
    • use the tip of the cap to break the seal and open the tube
    • wash the affected skin with soap and water and dry completely before applying
    • for athlete's foot wear well-fitting, ventilated shoes. Change shoes and socks at least once daily.
      • between the toes only: apply twice a day (morning and night) for 1 week or as directed by a doctor.
      • on the bottom or sides of the foot: apply twice a day (morning and night) for 2 weeks or as directed by a doctor.
    • for jock itch and ringworm: apply once a day (morning or night) for 1 week or as directed by a doctor.
    • wash hands after each use
  • children under 12 years: ask a doctor
1 week between the toes
Figure
2 weeks on the bottom or sides of the foot
Figure

Other information

Inactive ingredients

benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 30 g Tube Carton

sunmark®

athlete's foot cream

terbinafine hydrochloride cream 1%

antifungal cream

FULL PRESCRIPTION STRENGTH

NET WT 1 oz (30 g)

Principal Display Panel - 30 g Tube Carton
ATHLETES FOOT 
terbinafine hydrochloride cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:49348-790
Route of Administration TOPICAL
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride 1 g  in 100 g
Inactive Ingredients
Ingredient Name Strength
benzyl alcohol (UNII: LKG8494WBH)  
cetyl alcohol (UNII: 936JST6JCN)  
cetyl palmitate (UNII: 5ZA2S6B08X)  
isopropyl myristate (UNII: 0RE8K4LNJS)  
polysorbate 60 (UNII: CAL22UVI4M)  
water (UNII: 059QF0KO0R)  
sodium hydroxide (UNII: 55X04QC32I)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
stearyl alcohol (UNII: 2KR89I4H1Y)  
Product Characteristics
Color WHITE Score     
Shape Size
Flavor Imprint Code
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:49348-790-72 1 in 1 CARTON
1 30 g in 1 TUBE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077511 07/02/2007
Labeler - McKesson (177667227)
Establishment
Name Address ID/FEI Business Operations
Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(49348-790)

Revised: 12/2012
Document Id: 5ffb32df-6b19-436e-ac92-0a0ab5b6f550
Set id: fd853928-05e1-4db9-bb1d-6e6e6eaec7ed
Version: 1
Effective Time: 20121206
 
McKesson