MICONAZOLE NITRATE solution

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

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

Available from:

AvPAK

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Topical Antifungal Cures most athlete’s foot (tinea pedis) and ring worm (tinea corporis). Under professional supervision, Miconazole Nitrate 2% Solution can be used for the treatment of superficial skin infections caused by yeast (Candida albicans).

Product summary:

NDC# 50268-503-29 1 fl. oz. (29.57mL) bottle with brush applicator containing an alcohol-free clear solution.

Authorization status:

OTC monograph final

Summary of Product characteristics

MICONAZOLE NITRATE- MICONAZOLE NITRATE SOLUTION
AVPAK
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MICONAZOLE NITRATE 2% SOLUTION
TOPICAL ANTIFUNGALK
_DRUG FACTS_
ACTIVE INGREDIENT
Miconazole Nitrate 2%
INACTIVE INGREDIENTS
Glacial Acetic Acid, Laureth-4, Propylene glycol, Sodium Hydroxide,
Sodium Metabisulfite
PURPOSE
Topical Antifungal
USES
Cures most athlete’s foot (tinea pedis) and ring worm (tinea
corporis). Under
professional supervision, Miconazole Nitrate
2% Solution can be used for the treatment of superficial skin
infections caused by yeast
(Candida albicans).
WARNINGS
DO NOT USE ON CHILDREN UNDER TWO YEARS OF AGE EXCEPT UNDER THE ADVICE
AND SUPERVISION OF A
DOCTOR. FOR EXTERNAL USE ONLY. KEEP OUT OF THE REACH OF CHILDREN. In
case
of accidental ingestion, seek professional assistance or contact
Poison Control Center
immediately. Avoid contact with eyes. If irritation occurs or if there
is no improvement
within four weeks, discontinue use and consult a doctor or pharmacist.
Do not use if
you are diabetic or have circulatory, renal, or hepatic problems,
consult a doctor or
pharmacist before using.
DIRECTIONS
Cleanse and dry affected areas. Apply a thin application twice a day
(morning and night)
on skin under nails and surrounding
cuticle areas or as recommended by your doctor or pharmacist. Remove
Miconazole
Nitrate 2% Solution from any untreated areas.
Remove from all inanimate environmental surfaces. 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 a day. For
well fitting, ventilated shoes and change shoes and socks at least
once a day. For
athlete’s foot and ringworm use daily for 4 weeks. For fungal
infections of the nail bed, if
conditions persist, consult a doctor who may choose to debride or
remove the nail to
allow application of Miconazole Nitrate 2% Solution to the skin of the
nail bed. This
product is not effective on the scalp or nails.
OTHER INFORMATION
Store at 20°C to 2