MICONAZOLE- miconazole nitrate cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

Chain Drug Consortium, LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Antifungal - proven clinically effective in the treatment of most athlete's foot, jock itch, and ringworm - for effective relief of itching, scaling, cracking, burning, and discomfort

Authorization status:

OTC monograph final

Summary of Product characteristics

MICONAZOLE- MICONAZOLE NITRATE CREAM
CHAIN DRUG CONSORTIUM, LLC
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MICONAZOLE NITRATE CREAM, USP
_DRUG FACTS_
_ACTIVE INGREDIENT_
Miconazole nitrate, USP 2%
_PURPOSE_
Antifungal
_USES_
proven clinically effective in the treatment of most athlete's foot,
jock itch, and
ringworm
for effective relief of itching, scaling, cracking, burning, and
discomfort
_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
there is no improvement within 4 weeks (for athlete's foot and
ringworm) or within 2
weeks (for jock itch)
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
(1-800-222-
1222) right away.
_DIRECTIONS_
clean the affected area and dry thoroughly
apply a thin layer of the product over affected area twice daily
(morning and night),
or as directed by a doctor
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 lasts longer, contact a doctor
this product is not effective on the scalp or nails
_OTHER INFORMATION_
do not use if foil seal on tube opening is broken or missing
to open tube: unscrew cap, lift tab, and pull to remove foil seal
prior to use
store at room temperature 15-30°C (59-86°F)
before using any medication, read all label directions. Keep carton,
it contains
important information.
_INACTIVE INGREDIENTS_
benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl
polyoxylglycerides, pegoxol 7
stearate, purified water
QUESTIONS OR COMMENTS?
Call 1-877-753-3935 Monday-Friday 9AM-5PM EST
PRINCIPAL DISPLAY PANEL
COMPARE TO THE ACTIVE INGREDIENT IN MICARIN® ANTIFUNGAL CREAM*
Antifungal Cream
Miconazole nitrate cream, USP 2%
Cures Most
Athlete's Foot,
Jock It