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VAGISTEN-V 7 DAY by OPMX LLC

Medically reviewed by Drugs.com. Last updated on Sep 6, 2018.

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 2g in 100g
Labeler: OPMX LLC
NDC Code: 69729-612

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

ACTIVE INGREDIENTS

MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

PURPOSE

VAGINAL ANTIFUNGAL

USES
  • TREATS VAGINAL YEAST INFECTIONS
  • RELIEVES EXTERNAL ITCHING AND URINATION DUE TO 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 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.

Keep out of reach of children

  • If swallowed get medical help or contact Poison Control Center right away.

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.

INACTIVE INGREDIENTS

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

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)

VAGISTEN-V  7 DAY
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69729-612
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
MICONAZOLE NITRATE (MICONAZOLE) MICONAZOLE NITRATE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
GLYCERYL MONOSTEARATE 
MINERAL OIL 
PEG-5 OLEATE 
PEGOXOL 7 STEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:69729-612-051 TUBE in 1 BOX
1NDC:69729-612-0114 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart333C09/05/2018
Labeler - OPMX LLC (029918743)

 
OPMX LLC

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