MICONAZOLE NITRATE cream

Land: USA

Språk: engelsk

Kilde: NLM (National Library of Medicine)

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Last ned Preparatomtale (SPC)
13-01-2023

Aktiv ingrediens:

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

Tilgjengelig fra:

H2-Pharma, LLC

Administreringsrute:

TOPICAL

Resept typen:

OTC DRUG

Indikasjoner:

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

Autorisasjon status:

OTC monograph final

Preparatomtale

                                MICONAZOLE NITRATE- MICONAZOLE NITRATE CREAM
H2-PHARMA, 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._
----------
MICONAZOLE NITRATE
_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 the 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-F
                                
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