Vagisten-v Cream
FDA Label NDC 69729-612

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Opmx Llc for the product Vagisten-v (NDC 69729-612). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purpose, uses, warnings, otc - keep out of reach of children, directions, inactive ingredients, other information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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.

Otc - Keep Out Of Reach Of Children

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)

Package Label.Principal Display Panel

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