ATHLETES FOOT- terbinafine hydrochloride cream 
Strategic Sourcing Services LLC

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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 TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-790
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP) Terbinafine Hydrochloride1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-790-721 in 1 CARTON12/12/2012
130 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/2007
Labeler - Strategic Sourcing Services LLC (116956644)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-790)

Revised: 11/2019
Document Id: d211068d-28a6-42fe-8b7e-ffa481950b11
Set id: fd853928-05e1-4db9-bb1d-6e6e6eaec7ed
Version: 2
Effective Time: 20191126
 
Strategic Sourcing Services LLC