Monistat 7 7-day disposable applicators cream

Spl unclassified section

Drug Facts

Active ingredient

Miconazole nitrate 2% (100 mg in each applicatorful)

Purpose

Vaginal antifungal

Uses

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

Warnings

For vaginal use only

Otc - do not use section

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Otc - ask doctor section

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

Otc - ask doctor/pharmacist section

Ask a doctor or pharmacist before use if you aretaking the prescription blood thinning medicine warfarin, because bleeding or bruising may occur

Otc - when using section

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

Otc - stop use section

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

Otc - pregnancy or breast feeding section

If pregnant or breast-feeding,ask a health professional before use.

Otc - keep out of reach of children section

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 1 applicatorful into the vagina at bedtime for 7 nights in a row. Throw away 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, irritate 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

  • do not use if seal over tube opening has been punctured or embossed design Monistat 7 7-day disposable applicatorsnot visible

  • do not purchase if carton is open
  • store at 20-25C (68-77F)

Inactive ingredients

  • benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol

Questions?

If you have any questions or comments, please call 1-877-666-4782

Ingredients and appearance - Product information

Monistat 7 7-day disposable applicators cream- Miconazole nitrate

Product information

Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC: 30014-024
Route of Administration Vaginal

Active Ingredient/Active Moiety

Ingredient Name Strength
Miconazole nitrate ( UNII: VW4H1CYW1K)( Miconazole - UNII: 7NNO0D7S5M ) 20 mgin 1 g

Inactive Ingredients

Ingredient Name Code
Benzoic acid ( UNII: 8SKN0B0MIM)
Cetyl alcohol ( UNII: 936JST6JCN)
Isopropyl myristate ( UNII: 0RE8K4LNJS)
Polysorbate 60 ( UNII: CAL22UVI4M)
Potassium hydroxide ( UNII: WZH3C48M4T)
Propylene glycol ( UNII: 6DC9Q167V3)
Water ( UNII: 059QF0KO0R)
Stearyl alcohol ( UNII: 2KR89I4H1Y)

Product Characteristics

Marketing Information

Marketing Category Application Number or Monograph Citation Territorial Authority Marketing Start Date
NDA NDA017450 USA

Labeler - McNeil-PPC, Inc.( 801375143)

Principal display panel - 45g tube carton

NDC 30014-024-15

MONISTAT ®7
Miconazole Nitrate Vaginal Cream (2%)
Vaginal Antifungal

(Miconazole Nitrate 100 mg per application)

CURES MOST VAGINAL YEAST INFECTIONS
AND RELIEVES ASSOCIATED EXTERNAL ITCHING AND IRRITATION

ORTHO

7 Day Vaginal Cream
with Disposable Applicators

Net Wt.
1.59 oz. (45g) tube