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Miconazole Nitrate by REMEDYREPACK INC.

Medically reviewed on October 31, 2017

Dosage form: cream
Ingredients: MICONAZOLE NITRATE 20mg in 1g
Labeler: REMEDYREPACK INC.
NDC Code: 70518-0811

Miconazole Nitrate Vaginal Cream 2 %

7 Day Vaginal Cream

ACTIVE INGREDIENT

Miconazole nitrate 2% (100 mg in each applicator)
Miconazole nitrate 2% (as external cream)

PURPOSE

Vaginal antifungal

USES

• treats repeat vaginal yeast infections
• relieves external itching and irritation due to a repeat 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 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,

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.

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

• do not use if seal over tube opening has been punctured or cannot be seen
• store at room temperature 15°-30°C (59°-86°F). Avoid heat over 30°C or 86°F.

INACTIVE INGREDIENT

benzoic acid, BHA, mineral oil, peglicol 5 oleate, pegoxol 7 stearate, purified water

QUESTIONS

1-800-922-1038

DRUG: Miconazole Nitrate

GENERIC: Miconazole Nitrate

DOSAGE: CREAM

ADMINSTRATION: VAGINAL

NDC: 70518-0811-0

PACKAGING: 45 g in 1 TUBE, WITH APPLICATOR

ACTIVE INGREDIENT(S):

  • Miconazole Nitrate 20mg in 1g

INACTIVE INGREDIENT(S):

  • Benzoic Acid
  • Peg-5 Oleate
  • Pegoxol 7 Stearate
  • Butylated Hydroxyanisole
  • Mineral Oil
  • Water

MICONAZOLE NITRATE 
miconazole nitrate cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70518-0811(NDC:0713-0252)
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
BENZOIC ACID 
BUTYLATED HYDROXYANISOLE 
MINERAL OIL 
PEG-5 OLEATE 
PEGOXOL 7 STEARATE 
WATER 
Packaging
#Item CodePackage Description
1NDC:70518-0811-045 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07436610/31/2017
Labeler - REMEDYREPACK INC. (829572556)

 
REMEDYREPACK 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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