Label: MICONAZOLE NITRATE- miconazole nitrate cream
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Contains inactivated NDC Code(s)
NDC Code(s): 76413-318-45 - Packager: Central Texas Community Health Centers
- This is a repackaged label.
- Source NDC Code(s): 0713-0252
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated April 21, 2016
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USES
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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
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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
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PRINCIPAL DISPLAY PANEL - 45 g Tube Label
CommUnityCare Federally Qualified Health Centers
MICONAZOLE
2% VAGINAL
CREAMDate:
Name:
Dr.USE AS DIRECTED
123456
1/1/01
MICONAZOLE 2% VAG.CRM 45gNDC 76413-318-45
Batch: 123456
Lot: 123456
Exp: 1/1/01
G&W LABSFederal law prohibits the transfer of this drug to any other person than the patient for whom prescribed.
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INGREDIENTS AND APPEARANCE
MICONAZOLE NITRATE
miconazole nitrate creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:76413-318(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:76413-318-45 1 in 1 CARTON 02/22/1996 1 45 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA074366 02/22/1996 Labeler - Central Texas Community Health Centers (079674019) Establishment Name Address ID/FEI Business Operations Central Texas Community Health Centers 079674019 REPACK(76413-318) , RELABEL(76413-318)