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Miconazole Nitrate by Taro Pharmaceuticals U.S.A., Inc.

Medically reviewed on May 2, 2018

Dosage form: cream
Ingredients: Miconazole Nitrate 20mg in 1g
Labeler: Taro Pharmaceuticals U.S.A., Inc.
NDC Code: 51672-2035

Miconazole Nitrate

Drug Facts

Active ingredient

Miconazole Nitrate USP 2% (100 mg per applicator)

Purpose

Vaginal Antifungal

Uses
  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

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
  • if you do not get complete relief ask a doctor before using another product.

Stop use and ask a doctor if

  • symptoms do not get better after 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.

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:
    • applicator: insert one applicatorful into the vagina at bedtime for 7 nights in a row. Wash applicator after 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: ask a doctor

Other information
  • do not purchase if carton is opened
  • do not use if seal over tube opening has been punctured or is not visible

To open: unscrew cap, use pointed end on cap to puncture seal

To close: screw cap back onto the tube

  • store at 20°-25°C (68°-77°F)
  • see carton or tube crimp for lot number and expiration date

Inactive ingredients

Apricot Kernel Oil/PEG-6, Butylated Hydroxytoluene, Mineral Oil, PEG-6-32 Stearate/Glycol Stearate, Purified Water and Benzoic Acid (0.20%) as a preservative

Questions?

Call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals
U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 45 g 1 Reusable Applicator Carton

Cures Most Vaginal Yeast Infections
and Relieves Associated External Itching and Irritation

7 Day Treatment

7 Day Vaginal Cream

Miconazole Nitrate Vaginal Cream USP (2%)
Vaginal Antifungal
(Miconazole Nitrate 100 mg per applicator)

One 45 g (1.5 oz) Tube Of Miconazole Nitrate Vaginal Cream USP (2%)
& 1 Reusable Applicator

Educational Brochure Enclosed

MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2035
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Miconazole Nitrate (Miconazole) Miconazole Nitrate20 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Butylated Hydroxytoluene 
Mineral Oil 
Water 
Benzoic Acid 
Packaging
#Item CodePackage Description
1NDC:51672-2035-61 TUBE, WITH APPLICATOR (TUBE) in 1 CARTON
145 g in 1 TUBE, WITH APPLICATOR
2NDC:51672-2035-71 TUBE, WITH APPLICATOR (TUBE) in 1 CARTON
245 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07444401/13/1997
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIOperations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2035)

 
Taro Pharmaceuticals U.S.A., Inc.

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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