TERBINAFINE HYDROCHLORIDE cream

Land: Vereinigte Staaten

Sprache: Englisch

Quelle: NLM (National Library of Medicine)

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Herunterladen Fachinformation (SPC)
29-07-2020

Wirkstoff:

Terbinafine Hydrochloride (UNII: 012C11ZU6G) (Terbinafine - UNII:G7RIW8S0XP)

Verfügbar ab:

Taro Pharmaceuticals U.S.A., Inc.

Verabreichungsweg:

TOPICAL

Verschreibungstyp:

OTC DRUG

Anwendungsgebiete:

Antifungal - cures most jock itch (tinea cruris) - relieves itching, burning, cracking and scaling which accompany this condition

Berechtigungsstatus:

Abbreviated New Drug Application

Fachinformation

                                TERBINAFINE HYDROCHLORIDE- TERBINAFINE HYDROCHLORIDE CREAM
TARO PHARMACEUTICALS U.S.A., INC.
----------
TERBINAFINE HYDROCHLORIDE
_DRUG FACTS_
ACTIVE INGREDIENT
Terbinafine hydrochloride 1%
PURPOSE
Antifungal
USES
cures most jock itch (tinea cruris)
relieves itching, burning, cracking and scaling which accompany this
condition
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE
on nails or scalp
in or near the mouth or eyes
for vaginal yeast infections
WHEN USING THIS PRODUCT do not get into 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 over:
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
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
OTHER INFORMATION
TAMPER EVIDENT: DO NOT USE IF THE SEAL ON THE TUBE IS PUNCTURED OR
NOT VISIBLE.
store at controlled room temperature 20° to 25°C (68° to 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 1-866-923-4914
Distributed by:
TARO PHARMACEUTICALS U.S.A., INC.
Hawthorne, NY 10532
PRINCIPAL DISPLAY PANEL - 12 G TUBE CARTON
Cures Most Jock Itch
Full Prescription Strength
Terbinafine Hydrochloride
Cream 1%
Antifungal
NET WT 0.42 oz (12 g)
TERBINAFINE HYDROCHLORIDE
terbinafine hydrochloride cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:51672-2083
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACTIVE MOIETY
INGREDIENT NAME
BASIS OF STRENGTH
STRENGTH
TERBINAFINE HYDROCHLORIDE (UNII: 012C11ZU6G) (Terbinafine -
UNII:G7RIW8S0XP)
Terbinafine
                                
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