Your browser does not support JavaScript! TERBINAFINE HYDROCHLORIDE CREAM [CARDINAL HEALTH]
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RxNorm Names

TERBINAFINE HYDROCHLORIDE cream
[Cardinal Health]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL Abbreviated New Drug Application
Drug Label Sections

Drug Facts

Active ingredient

Terbinafine hydrochloride 1%

Purpose

Antifungal

Uses

  • cures most athlete's foot (tinea pedis)
  • cures most jock itch (tinea cruris) and ringworm (tinea corporis)
  • relieves itching, burning, cracking and scaling which accompany these conditions

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.

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
2 weeks on the bottom
or sides of the foot
FigureFigure

Other information

  • do not use if seal on tube is broken or is not visible
  • store at controlled room temperature 20°-25°C (68°-77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

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

Questions?

Call 1-800-200-6313

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017

PRINCIPAL DISPLAY PANEL - 15 g Tube Carton

Leader®

CURES MOST ATHLETE'S FOOT
Athlete's Foot Cream
Terbinafine Hydrochloride Cream 1%
Antifungal Cream

SATISFACTION
• GUARANTEED •

NET WT 1/2 oz (15 g)

Principal Display Panel - 15 g Tube Carton
TERBINAFINE HYDROCHLORIDE 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:37205-941
Route of AdministrationTOPICALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Terbinafine Hydrochloride (Terbinafine) Terbinafine Hydrochloride1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetyl alcohol 
cetyl palmitate 
isopropyl myristate 
polysorbate 60 
water 
sodium hydroxide 
sorbitan monostearate 
stearyl alcohol 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:37205-941-991 in 1 CARTON
115 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751107/02/2007
Labeler - Cardinal Health (097537435)
Registrant - Taro Pharmaceuticals Inc. (206263295)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(37205-941)

Revised: 12/2011
 
Cardinal Health

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