CLOTRIMAZOLE- clotrimazole cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

Clotrimazole, USP1% (50 mg in each applicatorful), Clotrimazole, USP1% (external cream)

Available from:

REMEDYREPACK INC.

Administration route:

VAGINAL

Prescription type:

OTC DRUG

Therapeutic indications:

Vaginal antifungal Vaginal antifungal - treats vaginal yeast infections - relieves external itching and irritation due to a vaginal yeast infection

Authorization status:

Abbreviated New Drug Application

Summary of Product characteristics

CLOTRIMAZOLE- CLOTRIMAZOLE CREAM
REMEDYREPACK INC.
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CLOTRIMAZOLE VAGINAL CREAM, USP
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Clotrimazole, USP 1% (50 mg in each applicatorful)
_ACTIVE INGREDIENTS_
Clotrimazole, USP 1% (external cream)
_PURPOSE_
Vaginal antifungal
_PURPOSE_
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
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 A 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
(1-800-222-1222) right away.
_DIRECTIONS_
before using this product, read the enclosed educational brochure for
complete directions and
information
adults and children 12 years of age and over:
VAGINAL CREAM: insert one applicatorful of cream into the vagina at
b