TERBINAFINE HYDROCHLORIDE- terbinafine hydrochloride cream 
Preferred Pharmaceuticals, Inc

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Terbinafine Hydrochloride
Cream 1%
Antifungal Cream

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.
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 1
2 weeks on the bottom or sides of the foot
Figure 2

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.

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 30 g Carton

Cures Most Athlete's Foot
Terbinafine Hydrochloride
Cream 1%
Antifungal Cream

Full Prescription Strength

NET WT 1 oz (30 g)

Terbinafine Hydrochloride Cream 1%
TERBINAFINE HYDROCHLORIDE 
terbinafine hydrochloride cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9814(NDC:51672-2080)
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:68788-9814-115 g in 1 TUBE; Type 0: Not a Combination Product04/05/2012
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07751104/05/2012
Labeler - Preferred Pharmaceuticals, Inc (791119022)
Registrant - Preferred Pharmaceuticals, Inc (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc791119022RELABEL(68788-9814)

Revised: 9/2023
Document Id: 41b23666-e3a2-4367-82db-fcd5bb056d5e
Set id: 6016e546-6c02-4af0-888c-c0899865c5f0
Version: 7
Effective Time: 20230927
 
Preferred Pharmaceuticals, Inc