VAGISTEN-V

Manufacturer
OPMX LLC
Effective date
2024-09-04
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:39:52

Label at a glance#

ProductVAGISTEN-V 7 DAY
Active ingredientMICONAZOLE NITRATE
Label structure9 sections

Indications and uses

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

Dosage and administration

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 ON...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)

PURPOSE

OTC - PURPOSE SECTION

VAGINAL ANTIFUNGAL

USES

INDICATIONS & USAGE SECTION

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

WARNINGS

WARNINGS SECTION

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 SECTION

Keep out of reach of children

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

DIRECTIONS

DOSAGE & ADMINISTRATION SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

OTHER INFORMATION

OTHER SAFETY 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

0-UC_VAGISTEN-V CREMA 2pct_front0-UC_VAGISTEN-V CREMA 2pct_front

0-UC_VAGISTEN-V CREMA 2pct_back0-UC_VAGISTEN-V CREMA 2pct_back

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998540miconazole nitrate 2 % Vaginal CreamPSN2
998540miconazole nitrate 20 MG/ML Vaginal CreamSCD2
998540miconazole nitrate 2 % Vaginal CreamSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
MICONAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
3a55f4fb-5aec-4c88-0ff7-4d608ad4866aProduct name120140508
5b9a7965-36d2-8412-dcaf-f76a65411611Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69729-612-052024-11-29C16284748780-19d75b9d0-0c4c-f424-e053-dadaa90a57ceOPMX (as PLD) - Vagisten-V (69729-612)
69729-612-052020-01-31C16284748780-19d75b9d0-0c4c-f424-e053-dadaa90a57ceOPMX (as PLD) - Vagisten-V (69729-612)

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69729-612-01VAGISTEN-V7 DAY14 g in 1 TUBECREAM142
69729-612-05VAGISTEN-V7 DAY1 in 1 BOXCREAM12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69729-612VAGISTEN-V 7 DAY (MICONAZOLE NITRATE) CREAM [OPMX LLC]2Current NDC, Legacy NDC, 2 package rows20241201_a5bfa501-5ae1-4434-bc31-995d0665b99e.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69729-61269729-612-01, 69729-612-05

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
VAGISTEN-V 7 DAYMICONAZOLE NITRATEOPMX LLCa5bfa501-5ae1-4434-bc31-995d0665b99e2024-09-04WarningsExact identifier
ndc (package): 69729-612-01
ndc (package): 69729-612-05
ndc (product): 69729-612
ndc11 (package): 69729061205
ndc11 (package): 69729061201
spl id: 214e6edc-8028-e8d5-e063-6394a90af7a0
spl set id: a5bfa501-5ae1-4434-bc31-995d0665b99e

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.