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

& Chafing

NET WT 133g (4.6 OZ)

Label 133 g

LOTRIMIN ANTIFUNGAL
miconazole nitrate aerosol, powder

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:11523-4140
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M)	MICONAZOLE NITRATE	20 mg in 1 g

Ingredient Name	Strength
Inactive Ingredients
TALC (UNII: 7SEV7J4R1U)
ISOBUTANE (UNII: BXR49TP611)

Product Characteristics
Color	white (White to off-white)	Score
Shape		Size
Flavor		Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:11523-4140-2	133 g in 1 CAN; Type 0: Not a Combination Product	09/01/1993

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part333C	09/01/1993

Labeler - Bayer Healthcare LLC. (112117283)

Lotrimin ® Antifungal