LOTRIMIN ANTIFUNGAL- miconazole nitrate 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 - Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and ringworm (tinea corporis) - relieves itching, cracking, burning and scaling

Authorization status:

OTC monograph final

Summary of Product characteristics

LOTRIMIN ANTIFUNGAL- MICONAZOLE NITRATE 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
Cures most athlete's foot (tinea pedis), jock itch (tinea cruris) and
ringworm (tinea
corporis)
relieves itching, cracking, burning and scaling
WARNINGS
FOR EXTERNAL USE ONLY
DO NOT USE on children under 2 years of age unless directed by a
doctor.
WHEN USING THIS PRODUCT
avoid contact with the eyes
STOP USE AND ASK A DOCTOR IF
irritation occurs
if there is no improvement within 4 weeks (for athlete's foot and
ringworm) or 2
weeks (for jock itch)
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
sprinkle a thin layer over affected area twice daily (morning and
night)
supervise children in the use of this product
®
for athlete's foot: pay special attention to spaces between the toes;
wear well-fitting,
ventilated shoes and change shoes and socks at least once daily
for athlete's foot and ringworm, use daily for 4 weeks; for jock itch,
use daily for 2
weeks
if condition persists longer, ask a doctor
this product is not effective on the scalp or nails
OTHER INFORMATION
store between 20° to 25°C (68° to 77°F)
INACTIVE INGREDIENTS
benzethonium chloride, corn starch, kaolin, sodium bicarbonate,
starch/acrylates/acrylamide copolymer, zinc oxide
PRINCIPAL DISPLAY PANEL - 90G CAN LABEL
NDC 11523-0919-1
LOTRIMIN AF
ANTIFUNGAL
MICONAZOLE NITRATE
CURES MOST
ATHLETE'S FOOT
POWDER
ABSORBS MOISTURE
RELIEVES ITCHING,
BURNING & SCALING
NET WT 90g (3 OZ)
37871-00
®
LOTRIMIN ANTIFUNGAL
miconazole nitrate powder
PRODUCT INFORMATION
PRODUCT TYPE
HUMAN OTC DRUG
ITEM CODE (SOURCE)
NDC:11523-0919
ROUTE OF ADMINISTRATION
TOPICAL
Bayer HealthCare L