ANTIFUNGAL BODY- 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:

McKesson

INN (International Name):

MICONAZOLE NITRATE

Composition:

MICONAZOLE NITRATE 2 mg in 100 mL

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Antifungal Uses - for treatment of most athlete's foot (tinea pedis), jock itch (tinea cruris), ringworm (tinea corporis) - relieves itching,scaling, cracking, burning, redness, soreness, irritation, discomfort and chafing associated with jock itch - for treatment ofsuperficial skin infections caused by yeast (Candida albicans)

Authorization status:

OTC monograph final

Summary of Product characteristics

ANTIFUNGAL BODY- MICONAZOLE NITRATE CREAM
MCKES S ON
_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._
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MCKESSON ANTIFUNGAL BODY CREAM
_DRUG FACTS_
_ACTIVE INGREDIENT_
Miconazole Nitrate 2%
_PURPOSE_
Antifungal
_USES_
for treatment of most athlete's foot (tinea pedis), jock itch (tinea
cruris), ringworm (tinea corporis)
relieves itching,scaling, cracking, burning, redness, soreness,
irritation, discomfort and chafing
associated with jock itch
for treatment ofsuperficial skin infections caused by yeast (Candida
albicans)
_WARNINGS_
FOR EXTERNAL USE ONLY.
WHEN USING THIS PRODUCT
Do not get into eyes
STOP USE AND ASK A DOCTOR IF
irritation occurs or if there is no improvement within 4 weeks for
athlete's foot or ringworm, or
within 2 weeks for jock itch.
DO NOT USE ON
children under 2 years of age unless directed by a doctor
diaper rash
_KEEP OUT OF REACH OF CHILDREN._
If swallowed, get medical help or contact a poison control center
right away.
_DIRECTIONS_
Clean the affected area and dry thoroughly
Apply a thin layer of product over affected area twice daily (morning
and night), or as directed by a
physician
Supervise children in the use of this product
ATHLETE’S FOOT
Pay special attention to the spaces between toes
Wear well-fitting, ventilated shoes and change shoes and socksat least
once daily
ATHLETE’S FOOT AND RINGWORM
Use daily for 4 weeks
JOCK ITCH
Use daily for 2 weeks. If condition persists longer, consult a doctor.
This product is not effective on scalp or nails.
_INACTIVE INGREDIENTS_
Isopropyl Palmitate, Glyceryl Stearate, PEG 100 Stearate,
Cyclopentasiloxane, Cetearyl Alcohol,
Propylene Glycol, Polyquaternium-37, Propylene Glycol
Dicaprylate/Dicaprate, PPG-1 Trideceth-6,
Aloe Barbadensis Leaf Juice, Calcium Pantothenate (Vitamin B5),
Maltodextrin, Niacinamide (Vitamin
B3), Pyridoxine HCL (Vitamin B6), Silica, Sodium Ascorbyl Phospha