NDC | 69729-612-01, 69729-612-05 |
Set ID | a5bfa501-5ae1-4434-bc31-995d0665b99e |
Category | HUMAN OTC DRUG LABEL |
Packager | OPMX LLC |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | PART333C |
- ACTIVE INGREDIENTS
- PURPOSE
- USES
-
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
-
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
- OTHER INFORMATION
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
VAGISTEN-V 7 DAY
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69729-612 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 2 g in 100 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4) MINERAL OIL (UNII: T5L8T28FGP) PEG-5 OLEATE (UNII: 0240V77G50) PEGOXOL 7 STEARATE (UNII: 3EW5AXE5X5) WATER (UNII: 059QF0KO0R) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69729-612-05 1 in 1 BOX 09/05/2018 1 NDC:69729-612-01 14 g in 1 TUBE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph final part333C 09/05/2018 Labeler - OPMX LLC (029918743)