Label: MICONAZOLE 1 WALGREENS- miconazole nitrate kit
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Contains inactivated NDC Code(s)
NDC Code(s): 0363-5201-01 - Packager: WALGREEN COMPANY
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated August 30, 2021
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- Active ingredients
- Purpose
- Uses
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Warnings
For vaginal use only
Ask a doctor before use if you have
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vaginal itching and discomfort for the first time
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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 medicine warfarin, because bleeding or bruising may occur
When using this product
- do not use tampons, douches, spermicides or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
- do not have vaginal intercourse
- mild increase in vaginal burning, itching or irritation may occur
- if you do not get complete relief ask a doctor before using another product
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vaginal itching and discomfort for the first time
- Keep out of reach of children.
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Directions
- before using this product read the enclosed consumer information leaflet for complete directions and information
- adults and children 12 years of age and over:
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vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away after use.
- external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the itchy, irritated skin outside the vagina (vulva). Use 2 times daily for up to 7 days, as needed.
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vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away after use.
- children under 12 years of age: ask a doctor
- before using this product read the enclosed consumer information leaflet for complete directions and information
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Other information
- do not use if printed sealed pouch is torn, open or incompletely sealed
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F)
- this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.
- do not use if printed sealed pouch is torn, open or incompletely sealed
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL - Kit Carton
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INGREDIENTS AND APPEARANCE
MICONAZOLE 1 WALGREENS
miconazole nitrate kitProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:0363-5201 Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:0363-5201-01 1 in 1 PACKAGE, COMBINATION; Type 0: Not a Combination Product 11/30/2021 Quantity of Parts Part # Package Quantity Total Product Quantity Part 1 1 POUCH 1 Part 2 1 TUBE 9 g Part 1 of 2 MICONAZOLE NITRATE
miconazole nitrate suppositoryProduct Information Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (UNII: VW4H1CYW1K) (Miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 1200 mg Inactive Ingredients Ingredient Name Strength Gelatin (UNII: 2G86QN327L) Glycerin (UNII: PDC6A3C0OX) Mineral Oil (UNII: T5L8T28FGP) Titanium Dioxide (UNII: 15FIX9V2JP) Petrolatum (UNII: 4T6H12BN9U) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 1 in 1 POUCH; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021308 11/30/2021 Part 2 of 2 MICONAZOLE NITRATE
miconazole nitrate creamProduct Information 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) Cetyl Alcohol (UNII: 936JST6JCN) Isopropyl Myristate (UNII: 0RE8K4LNJS) Polysorbate 60 (UNII: CAL22UVI4M) Potassium Hydroxide (UNII: WZH3C48M4T) Propylene Glycol (UNII: 6DC9Q167V3) Water (UNII: 059QF0KO0R) Stearyl Alcohol (UNII: 2KR89I4H1Y) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 9 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 NDA NDA021308 11/30/2021 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021308 11/30/2021 Labeler - WALGREEN COMPANY (008965063) Registrant - Insight Pharmaceuticals (055665422)
