LOTRIMIN ULTRA- butenafine hydrochloride cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

BUTENAFINE HYDROCHLORIDE (UNII: R8XA2029ZI) (BUTENAFINE - UNII:91Y494NL0X)

Available from:

Bayer Healthcare LLC.

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal - cures most athlete's foot between the toes. Effectiveness on the bottom or sides of foot is unknown. - relieves itching, burning, cracking, and scaling which accompany this condition - on nails or scalp - in or near the mouth or the eyes - for vaginal yeast infections Stop use and ask a doctor if too much irritation occurs or irritation gets worse

Authorization status:

New Drug Application

Summary of Product characteristics

LOTRIMIN ULTRA- BUTENAFINE HYDROCHLORIDE CREAM
BAYER HEALTHCARE LLC.
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LOTRIMIN ULTRA ®
_DRUG FACTS_
_ACTIVE INGREDIENT_
Butenafine hydrochloride 1%
_PURPOSE_
Antifungal
_USES_
cures most athlete's foot between the toes. Effectiveness on the
bottom or sides of
foot is unknown.
relieves itching, burning, cracking, and scaling which accompany this
condition
_WARNINGS_
FOR EXTERNAL USE ONLY
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 irritation
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:
wash the affected skin with soap and water and dry completely before
applying
to open the applicator, twist the base to the ON position. Squeeze
tube to
dispense cream.
FOR ATHLETE'S FOOT BETWEEN THE TOES: apply to affected skin between
and
around the toes twice a day for 1 week (morning and night), or once a
day for 4
weeks, or as directed by a doctor. Wear well-fitting, ventilated
shoes. Change
shoes and socks at least once daily.
wipe applicator tip with a tissue and close the applicator by twisting
the base to
the OFF position
wash hands after each use
children under 12 years: ask a doctor
_OTHER INFORMATION_
store between 20° to 25°C (68° to 77°F)
_INACTIVE INGREDIENTS_
benzyl alcohol, cetyl alcohol, glycerin, glyceryl monostearate SE,
polyoxyethylene (23)
cetyl ether, propylene glycol dicaprylate, purified water, sodium
benzoate, stearic acid,
trolamine, white petrolatum
_QUESTIONS?_
1-866-360-3266 or visit us at www.lotrimin.com
​LOTRIMIN ULTRA ®
BUTENAFINE HYDROCHLORIDE CREAM 1% ANTIFUNGAL
NET WT 20g (0.70 OZ)
LOTRIMIN ULTRA
butenafine hydrochloride cream
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:11523-0082
ROUTE OF ADMINISTRATION
TOPICAL
ACTIVE INGREDIENT/ACT