LOTRIMIN ANTIFUNGAL- miconazole nitrate aerosol, powder

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)

Available from:

Bayer Healthcare LLC.

INN (International Name):

MICONAZOLE NITRATE

Composition:

MICONAZOLE NITRATE 20 mg in 1 g

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal - proven clinically effective in the treatment of most jock itch (tinea cruris) - for effective relief of itching, burning, scaling and discomfort, and chafing associated with jock itch

Authorization status:

OTC monograph final

Summary of Product characteristics

LOTRIMIN ANTIFUNGAL- MICONAZOLE NITRATE AEROSOL, POWDER
BAYER HEALTHCARE LLC.
_Disclaimer: Most OTC drugs are not reviewed and approved by FDA,
however they may_
_be marketed if they comply with applicable regulations and policies.
FDA has not_
_evaluated whether this product complies._
----------
LOTRIMIN
ANTIFUNGAL
_DRUG FACTS_
ACTIVE INGREDIENT
Miconazole nitrate 2%
PURPOSE
Antifungal
USES
proven clinically effective in the treatment of most jock itch (tinea
cruris)
for effective relief of itching, burning, scaling and discomfort, and
chafing associated
with jock itch
WARNINGS
FOR EXTERNAL USE ONLY
FLAMMABLE: Do not use while smoking or near heat or flame
DO NOT USE on children under 2 years of age except under the advice
and supervision
of a doctor.
WHEN USING THIS PRODUCT
avoid contact with the eyes
use only as directed. Intentional misuse by deliberately concentrating
and inhaling
contents can be harmful or fatal
contents under pressure. Do not puncture or incinerate. Do not store
at temperature
above 120°F.
STOP USE AND ASK A DOCTOR IF
irritation occurs
there is no improvement within 2 weeks
KEEP OUT OF REACH OF CHILDREN. If swallowed, get medical help or
contact a Poison
Control Center right away.
®
DIRECTIONS
wash affected area and dry thoroughly
shake can well and spray a thin layer over affected area twice daily
(morning and
night)
supervise children in the use of this product
use daily for 2 weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails
in case of clogging, clean nozzle with a pin
OTHER INFORMATION
store between 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENTS
Inactive ingredients isobutane, SD alcohol 40-B (8% v/v),
stearalkonium hectorite, talc
QUESTIONS?
1-866-360-3266
DISTRIBUTION
Distributed by Bayer HealthCare LLC, Whippany NJ 07981 USA
PRINCIPAL DISPLAY PANEL - 133 G CAN LABEL
POWDER SPRAY
GOES ON DRY
NDC 11523-4140-2
LOTRIMIN AF
ANTIFUNGAL
MICONAZOLE NITRATE
CLINICALLY PROVEN TO CURE
MOST JOCK ITCH
Relieves Itching,
Burning, Scaling
®