Physicians Total Care, Inc. Terbinafine Hydrochloride
Terbinafine Hydrochloride by Physicians Total Care, Inc.
Dosage form: cream
Ingredients: Terbinafine Hydrochloride 1g in 100g Labeler: Physicians Total Care, Inc. NDC Code: 54868-5992
Cream 1% Antifungal Cream
Terbinafine hydrochloride 1%
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
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.
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
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
benzyl alcohol, cetyl alcohol, cetyl palmitate, isopropyl myristate, polysorbate 60, purified water, sodium hydroxide, sorbitan monostearate, stearyl alcohol.
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532
Additional barcode labeling by:
Physicians Total Care, Inc. Tulsa, Oklahoma 74146
PRINCIPAL DISPLAY PANEL - 30 g Carton
Cures Most Athlete's Foot
Cream 1% Antifungal Cream
Full Prescription Strength
NET WT 1 oz (30 g)
terbinafine hydrochloride cream
Product Type HUMAN OTC DRUG Item Code (Source) NDC:54868-5992(NDC:51672-2080)
Route of Administration TOPICAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Terbinafine Hydrochloride (Terbinafine) Terbinafine Hydrochloride 1 g in 100 g
Ingredient Name Strength
Color WHITE Score
Flavor Imprint Code
# Item Code Package Description
1 NDC:54868-5992-0 1 TUBE (TUBE) in 1 CARTON
1 30 g in 1 TUBE
2 NDC:54868-5992-1 1 TUBE (TUBE) in 1 CARTON
2 15 g in 1 TUBE
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA077511 02/24/2009
Labeler - Physicians Total Care, Inc.
Name Address ID/FEI Operations
Physicians Total Care, Inc. 194123980 relabel(54868-5992)
Physicians Total Care, Inc.
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