Opmx (as Pld) - Vagisten-v (69729-612)

Opmx (as Pld) - Vagisten-v (69729-612)
SPL v2
SPL
SPL Set ID a5bfa501-5ae1-4434-bc31-995d0665b99e
Route
VAGINAL
Published
Effective Date 2018-09-06
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Miconazole (2 g)
Inactive Ingredients
Benzoic Acid Butylated Hydroxyanisole Glyceryl Monostearate Mineral Oil Peg-5 Oleate Pegoxol 7 Stearate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-09-05

Description

MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

Purpose

VAGINAL ANTIFUNGAL


Medication Information

Purpose

VAGINAL ANTIFUNGAL

Description

MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

Uses
  • TREATS VAGINAL YEAST INFECTIONS
  • RELIEVES EXTERNAL ITCHING AND URINATION DUE TO VAGINAL YEAST INFECTION

Section 50565-1

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.
Section 51945-4

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 FIRST TIME
  • LOWER ABDOMINAL, BACK OR SHOULDER PAIN, FEVER, CHILLS, NASEA, 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 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 HAVE TAKEN A PRESCRIPTION BLOOD THINNING MEDICINE, SUCH AS WARFARIN, BECAUSE BLEEDING OR BRUISING MAY OCCUR.

WHEN USING THIS PRODUCT

  • DO NOT USE TAMPONS, DOUCHES, SPERMACIDES OR OTHER VAGINAL PRODUCTS. CONDOMS AND DIAPHRAGMS MAY BE DAMAGED OR FAIL TO PREVENT PREGNANCY OR SEXUALLY TRANSMITTED DISEASES (STDS).
  • DO NOT HAVE VAGINAL INTERCOURSE
  • MILD INCREASE IN VAGINAL BURNING, ITCHING OR IRRITATION MAY OCCUR.

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 HIVESS, ABDOMINAL PAIN, FEVER, CHILLS, NAUSEA, VOMITING OR FOUL-SMELLING DISCHARGE

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Directions
  • BEFORE USING THIS PRODUCT READ THE ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE DIRECTIONS AND INFORMATION
  • ADULTS AND CHILDREN 12 YEARS OF AGE OR OVER:
  • APPLICATOR: INSERT 1 APPLICATOR INTO THE VAGINA AT BEDTIME FOR 7 NIGHTS IN A ROW. THROW APPLICATOR AWAY AFTER USE.
  • EXTERNAL CREAM: USE THE SAME TUBE OF CREAM IF YOU HAVE ITCHING AND IRRITATION ON THE SKIN OUTSIDE THE VAGINA. SQUEEZE A SMALL AMOUNT OF CREAM ONTO YOUR FINGERTIP. APPLY TO ITCHY, IRRITATED SKIN OUTSIDE THE VAGINA (VULVA). USE 2 TIMES DAILY FOR UP TO 7 DAYS AS NEEDED.
  • CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.

Other Information
  • DO NOT USE IF SEAL TUBE OPENING HAS BEEN PUNCTURED
  • DO NOT PURCHASE IF CARTON OPEN
  • STORE AT 20° - 25°C (68°F - 77°F)
Active Ingredients

MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

Inactive Ingredients

BENZOIC ACID, BUTYLATED HYDROXYANISOLE, GLYCERINE STEARATE, MINERAL OIL, PEGLICOL 5 OLEATE, PEGOXOL 7 STEARATE, PURIFIED WATER


Structured Label Content

Uses (USES)
  • TREATS VAGINAL YEAST INFECTIONS
  • RELIEVES EXTERNAL ITCHING AND URINATION DUE TO VAGINAL YEAST INFECTION

Section 50565-1 (50565-1)

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.
Section 51945-4 (51945-4)

Purpose (PURPOSE)

VAGINAL ANTIFUNGAL

Warnings (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 FIRST TIME
  • LOWER ABDOMINAL, BACK OR SHOULDER PAIN, FEVER, CHILLS, NASEA, 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 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 HAVE TAKEN A PRESCRIPTION BLOOD THINNING MEDICINE, SUCH AS WARFARIN, BECAUSE BLEEDING OR BRUISING MAY OCCUR.

WHEN USING THIS PRODUCT

  • DO NOT USE TAMPONS, DOUCHES, SPERMACIDES OR OTHER VAGINAL PRODUCTS. CONDOMS AND DIAPHRAGMS MAY BE DAMAGED OR FAIL TO PREVENT PREGNANCY OR SEXUALLY TRANSMITTED DISEASES (STDS).
  • DO NOT HAVE VAGINAL INTERCOURSE
  • MILD INCREASE IN VAGINAL BURNING, ITCHING OR IRRITATION MAY OCCUR.

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 HIVESS, ABDOMINAL PAIN, FEVER, CHILLS, NAUSEA, VOMITING OR FOUL-SMELLING DISCHARGE

IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.

Directions (DIRECTIONS)
  • BEFORE USING THIS PRODUCT READ THE ENCLOSED CONSUMER INFORMATION LEAFLET FOR COMPLETE DIRECTIONS AND INFORMATION
  • ADULTS AND CHILDREN 12 YEARS OF AGE OR OVER:
  • APPLICATOR: INSERT 1 APPLICATOR INTO THE VAGINA AT BEDTIME FOR 7 NIGHTS IN A ROW. THROW APPLICATOR AWAY AFTER USE.
  • EXTERNAL CREAM: USE THE SAME TUBE OF CREAM IF YOU HAVE ITCHING AND IRRITATION ON THE SKIN OUTSIDE THE VAGINA. SQUEEZE A SMALL AMOUNT OF CREAM ONTO YOUR FINGERTIP. APPLY TO ITCHY, IRRITATED SKIN OUTSIDE THE VAGINA (VULVA). USE 2 TIMES DAILY FOR UP TO 7 DAYS AS NEEDED.
  • CHILDREN UNDER 12 YEARS OF AGE: ASK A DOCTOR.

Other Information (OTHER INFORMATION)
  • DO NOT USE IF SEAL TUBE OPENING HAS BEEN PUNCTURED
  • DO NOT PURCHASE IF CARTON OPEN
  • STORE AT 20° - 25°C (68°F - 77°F)
Active Ingredients (ACTIVE INGREDIENTS)

MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

Inactive Ingredients (INACTIVE INGREDIENTS)

BENZOIC ACID, BUTYLATED HYDROXYANISOLE, GLYCERINE STEARATE, MINERAL OIL, PEGLICOL 5 OLEATE, PEGOXOL 7 STEARATE, PURIFIED WATER


Advanced Ingredient Data


Raw Label Data

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