MICONAZOLE 1 COMBINATION PACK- miconazole nitrate kit

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M)

Available from:

CVS PHARMACY, INC

Prescription type:

OTC DRUG

Therapeutic indications:

Miconazole nitrate 1200 mg (in vaginal insert)             Vaginal antifungal Miconazole nitrate 2% (external cream)       Vaginal antifungal - treats vaginal yeast infections - relieves external itching and irritation due to a vaginal yeast infection

Authorization status:

New Drug Application

Summary of Product characteristics

MICONAZOLE 1 COMBINATION PACK- MICONAZOLE NITRATE
CVS PHARMACY, INC
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MICONAZOLE 1 COMBINATION PACK
DRUG FACTS
_ACTIVE INGREDIENTS_
_PURPOSE_
Miconazole nitrate 1200 mg (in vaginal insert) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal
USES
treats vaginal yeast infections
relieves external itching and irritation due to a vaginal yeast
infection
WARNINGS
FOR VAGINAL USE ONLY
DO NOT USE
IF YOU HAVE NEVER HAD A VAGINAL YEAST INFECTION DIAGNOSED BY A DOCTOR.
ASK A DOCTOR BEFORE USE IF YOU HAVE
VAGINAL ITCHING AND DISCOMFORT FOR THE FIRST TIME
LOWER ABDOMINAL, BACK OR SHOULDER PAIN, FEVER, CHILLS, NAUSEA,
VOMITING, OR
FOUL-SMELLING VAGINAL DISCHARGE. YOU MAY HAVE A MORE SERIOUS
CONDITION.
vaginal yeast infections often (such as once a month or 3 in 6
months). You could be
pregnant or have a serious underlying medical cause for your symptoms,
including
diabetes or a weakened immune system.
been exposed to the human immunodeficiency virus (HIV) that causes
AIDS
ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
taking the prescription blood thinning medicine warfarin, because
bleeding or bruising
may occur
WHEN USING THIS PRODUCT
do not use tampons, douches, spermicides or other vaginal products.
Condoms and
diaphragms may be damaged and fail to prevent pregnancy or sexually
transmitted
diseases (STDs).
do not have vaginal intercourse
mild increase in vaginal burning, itching or irritation may occur
if you do not get complete relief ask a doctor before using another
product
STOP USE AND ASK A DOCTOR IF
SYMPTOMS DO NOT GET BETTER IN 3 DAYS
SYMPTOMS LAST MORE THAN 7 DAYS
YOU GET A RASH OR HIVES, ABDOMINAL PAIN, FEVER, CHILLS, NAUSEA,
VOMITING, OR
FOUL-SMELLING VAGINAL DISCHARGE
IF PREGNANT OR BREAST-FEEDING,
ask a health professional before use.
KEEP OUT OF REACH OF CHILDREN.
If swallowed, get medical help or contact a Poison Control Center
right away.
DIRECTIONS
before using this product read the enclosed consumer information
leaflet for
complete directions and information
adults and