Indications and uses
TREATS VAGINAL YEAST INFECTIONS RELIEVES EXTERNAL ITCHING AND URINATION DUE TO VAGINAL YEAST INFECTION
TREATS VAGINAL YEAST INFECTIONS RELIEVES EXTERNAL ITCHING AND URINATION DUE TO VAGINAL YEAST INFECTION
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...
MICONOZOLE NITRATE 2% (100 MG IN EACH APPLICATOR)
VAGINAL ANTIFUNGAL
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
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
STOP USE AND ASK A DOCTOR IF
IF PREGNANT OR BREAST FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE.
Keep out of reach of children
BENZOIC ACID, BUTYLATED HYDROXYANISOLE, GLYCERINE STEARATE, MINERAL OIL, PEGLICOL 5 OLEATE, PEGOXOL 7 STEARATE, PURIFIED WATER
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 69517-612-05 | 2023-10-22 | C162847 | 48780-1 | ba0f9c33-57e4-a910-e053-dadaa90a0b85 | 2a3827df-fbee-4d03-9152-3bea4fbb4010 |
| 69517-612-05 | 2021-01-29 | C162847 | 48780-1 | ba0f9c33-57e4-a910-e053-dadaa90a0b85 | 2a3827df-fbee-4d03-9152-3bea4fbb4010 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 69517-612 | 69517-612-01, 69517-612-05 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| MICONAZOLE NITRATE | VW4H1CYW1K | ACTIB |
| BENZOIC ACID | 8SKN0B0MIM | IACT |
| BUTYLATED HYDROXYANISOLE | REK4960K2U | IACT |
| GLYCERYL MONOSTEARATE | 230OU9XXE4 | IACT |
| MINERAL OIL | T5L8T28FGP | IACT |
| PEG-5 OLEATE | 0240V77G50 | IACT |
| PEGOXOL 7 STEARATE | 3EW5AXE5X5 | IACT |
| WATER | 059QF0KO0R | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 08471624-1019-7d34-e063-6294a90a4f08 | 2a3827df-fbee-4d03-9152-3bea4fbb4010 | 2023-10-21 | Warnings | 2a3827df-fbee-4d03-9152-3bea4fbb4010 |
Adverse event summaries are temporarily unavailable. Other product information remains available.