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| Product NDC Code | 37205-589 | ||||
|---|---|---|---|---|---|
| Drug Name | Miconazole 3 combination pack |
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| Type | Brand | ||||
| Route | VAGINAL | ||||
| Dosage Form | KIT | ||||
| RxCUI drug identifier | 992765, 992766, 998540 |
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| Application Number | ANDA074926 | ||||
| Labeler Name | Cardinal Health (Leader) 37205 | ||||
| Packages |
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| Check if available Online | Get Medication Prices online with Discount |
Active ingredient
A list of the active, medicinal ingredients in the drug product.Active ingredients Miconazole nitrate, USP 200 mg (in each suppository) Miconazole nitrate, USP 2% (external cream)
Dosage and administration
Information about the drug product’s dosage and administration recommendations, including starting dose, dose range, titration regimens, and any other clinically sigificant information that affects dosing recommendations.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: suppositories: insert 1 suppository into the vagina at bedtime for 3 nights in a row. Wash applicator after each use. external cream: Use cap to puncture seal. Squeeze a small amount of cream onto your fingertip. Gently apply the cream onto the itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days, as needed. children under 12 years of age: ask a doctor
Inactive ingredient
A list of inactive, non-medicinal ingredients in a drug product.Inactive ingredients suppository: hydrogenated vegetable oil external cream: benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water
Indications and usage
A statement of each of the drug products indications for use, such as for the treatment, prevention, mitigation, cure, or diagnosis of a disease or condition, or of a manifestation of a recognized disease or condition, or for the relief of symptoms associated with a recognized disease or condition. This field may also describe any relevant limitations of use.Uses treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection
Purpose
Information about the drug product’s indications for use.Purpose Vaginal antifungal
Spl product data elements
Usually a list of ingredients in a drug product.Miconazole 3 Combination Pack miconazole nitrate miconazole 3 miconazole nitrate MICONAZOLE NITRATE MICONAZOLE HYDROGENATED PALM KERNEL OIL miconazole 3 miconazole nitrate MICONAZOLE NITRATE MICONAZOLE BENZOIC ACID BUTYLATED HYDROXYANISOLE MINERAL OIL APRICOT KERNEL OIL PEG-6 ESTERS PEGOXOL 7 STEARATE WATER
Package label principal display panel
The content of the principal display panel of the product package, usually including the product’s name, dosage forms, and other key information about the drug product.Principal Display Panel NDC 37205-589-03 LEADER ® 3 DAY TREATMENT Reusable Applicator VAGINAL SUPPOSITORIES plus CREAM for EXTERNAL RELIEF Compare to Monistat® 3 active ingredient* Miconazole 3 Combination Pack Miconazole Nitrate Vaginal Suppositories, USP 200 mg and Miconazole Nitrate External Vulvar Cream, 2% VAGINAL ANTIFUNGAL Cures most vaginal yeast infections Relieves associated external itching and irritation 3 Miconazole Nitrate Vaginal Suppositories, USP 200 mg plus 1 tube of Miconazole Nitrate External Vulvar Cream - NET WT 0.32 oz (9 g) image
Spl unclassified section
Information not classified as belonging to one of the other fields. Approximately 40% of labeling with effective_time between June 2009 and August 2014 have information in this field.Drug Facts
Ask doctor
Information about when a doctor should be consulted about existing conditions or sumptoms before using the drug product, including all warnings for persons with certain preexisting conditions (excluding pregnancy) and all warnings for persons experiencing certain symptoms. The warnings under this heading are those intended only for situations in which consumers should not use the product until a doctor is consulted.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 doctor or pharmacist
Information about when a doctor or pharmacist should be consulted about drug/drug or drug/food interactions before using a drug product.Ask a doctor or pharmacist before use if you are taking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur
Do not use
Information about all contraindications for use. These contraindications are absolute and are intended for situations in which consumers should not use the product unless a prior diagnosis has been established by a doctor or for situations in which certain consumers should not use the product under any circumstances regardless of whether a doctor or health professional is consulted.Do not use if you have never had a vaginal yeast infection diagnosed by a doctor
Keep out of reach of children
Information pertaining to whether the product should be kept out of the reach of children, and instructions about what to do in the case of accidental contact or ingestion, if appropriate.Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Other safety information
Information about safe use and handling of the product that may not have been specified in another field.Other information do not use if suppository wrapper is missing or damaged (each suppository is individually wrapped) do not use if seal over tube opening has been punctured or is not visible do not purchase if carton is open store at room temperature 15°-30°C (59°-86°F). Avoid heat (over 30°C - 86°F)
Questions
A telephone number of a source to answer questions about a drug product. Sometimes available days and times are also noted.Questions? 1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.
Stop use
Information about when use of the drug product should be discontinued immediately and a doctor consulted. Includes information about any signs of toxicity or other reactions that would necessitate immediately discontinuing use of the product.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
When using
Information about side effects that people may experience, and the substances (e.g. alcohol) or activities (e.g. operating machinery, driving a car) to avoid while using the drug product.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
Pregnancy or breast feeding
Pregnancy or Breast feedingIf pregnant or breast-feeding, ask a health professional before use.
Warnings
Information about serious adverse reactions and potential safety hazards, including limitations in use imposed by those hazards and steps that should be taken if they occur.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 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 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, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.
Disclaimer: Do not rely on openFDA or Phanrmacy Near Me to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Source: OpenFDA, Healthporta Drugs API