NDC | 0713-0252-37 |
Set ID | 7257b2ae-c0b2-520a-f83d-cf1f6d1343ee |
Category | HUMAN OTC DRUG LABEL |
Packager | Cosette Pharmaceuticals, Inc. |
Generic Name | |
Product Class | Azole Antifungal |
Product Number | |
Application Number | ANDA074366 |
- ACTIVE INGREDIENT
- 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 the first time
• lower abdominal, back or shoulder pain, fever, chills, nausea, 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 a 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 are taking the prescription blood thinning medication warfarin, because bleeding or bruising may occur.
When using this product
• do not use tampons, douches, spermicides, or other vaginal products
• do not have vaginal intercourse
• condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs)
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 hives, abdominal pain, fever, chills, nausea, vomiting,or foul-smelling vaginal discharge - IF PREGNANT OR BREAST FEEDING,
- KEEP OUT OF REACH OF CHILDREN
-
DOSAGE & ADMINISTRATION
• before using this product read the enclosed consumer information leaflet for complete instructions
• adults and children 12 years of age and over:
• applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row
• external cream: squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated
skin outside the vagina. Use daily for up to 7 days as needed
• children under 12 years of age: ask a doctor - OTHER INFORMATION
- INACTIVE INGREDIENT
- QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
-
INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0713-0252 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength MICONAZOLE NITRATE (UNII: VW4H1CYW1K) (MICONAZOLE - UNII:7NNO0D7S5M) MICONAZOLE NITRATE 20 mg in 1 g Inactive Ingredients Ingredient Name Strength BENZOIC ACID (UNII: 8SKN0B0MIM) BUTYLATED HYDROXYANISOLE (UNII: REK4960K2U) 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:0713-0252-37 45 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product 02/22/1996 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074366 02/22/1996 Labeler - Cosette Pharmaceuticals, Inc. (116918230) Registrant - Cosette Pharmaceuticals, Inc. (116918230) Establishment Name Address ID/FEI Business Operations Cosette Pharmaceuticals, Inc. 116918230 analysis(0713-0252) , manufacture(0713-0252) , label(0713-0252) , pack(0713-0252)