![MICONAZOLE 7 (MICONAZOLE NITRATE) CREAM [SHOPKO STORES OPERATING CO., LLC]](https://medic.hrt.org//dailymed/images/8134e0e6-1b9c-439c-92c6-9efe01e07fc6/miconazole-01.jpg)
| NDC | 37012-035-07 |
| Set ID | 8134e0e6-1b9c-439c-92c6-9efe01e07fc6 |
| Category | HUMAN OTC DRUG LABEL |
| Packager | Shopko Stores Operating Co., LLC |
| Generic Name | |
| Product Class | Azole Antifungal |
| Product Number | |
| Application Number | ANDA074444 |
- SPL UNCLASSIFIED SECTION
- Active ingredient (in each applicator)
- Purpose
- Uses
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Warnings
For vaginal use only
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 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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Directions
- before using this product read the consumer information leaflet for complete directions and information
- adults and children 12 years of age and over:
- applicators: insert 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away applicator after each use.
- 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
- Other information
- Inactive ingredients
- Questions?
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PRINCIPAL DISPLAY PANEL - 45 g Tube Carton
NDC 37012-035-07
SHOPKO®
*Compare to the active
ingredient in Monistat® 7*Miconazole 7
Miconazole Nitrate Vaginal Cream USP (2%)
Vaginal Antifungal
(Miconazole Nitrate 100 mg Per Applicator)7 Day Treatment
Educational Brochure
EnclosedOne 45 g (1.5 oz) Tube Of Miconazole Nitrate Vaginal Cream USP (2%)
& 7 Disposable Applicators
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INGREDIENTS AND APPEARANCE
MICONAZOLE 7
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:37012-035 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Miconazole Nitrate (UNII: VW4H1CYW1K) (miconazole - UNII:7NNO0D7S5M) Miconazole Nitrate 2 mg in 100 g Inactive Ingredients Ingredient Name Strength Butylated Hydroxytoluene (UNII: 1P9D0Z171K) Mineral Oil (UNII: T5L8T28FGP) Water (UNII: 059QF0KO0R) Benzoic Acid (UNII: 8SKN0B0MIM) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:37012-035-07 1 in 1 CARTON 1 45 g in 1 TUBE, WITH APPLICATOR Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074444 01/13/1997 Labeler - Shopko Stores Operating Co., LLC (023252638) Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370) Establishment Name Address ID/FEI Business Operations Taro Pharmaceuticals Inc. 206263295 MANUFACTURE(37012-035)