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Miconazole 7


SPL UNCLASSIFIED SECTION

Drug Facts


Active ingredient

Miconazole nitrate USP, 2% (100 mg in each 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


OTC - DO NOT USE SECTION

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

OTC - ASK DOCTOR/PHARMACIST SECTION

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 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 (1-800-222-1222) 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. 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 of age: ask a doctor

Other information

  • •to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
  • •do not use if foil seal on tube opening is broken or missing
  • •do not purchase if carton is open
  • •store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
  • •before using any medication, read all label directions. Keep carton, it contains important information.

Inactive ingredients

benzoic acid, butylated hydroxyanisole, mineral oil, oleoyl polyoxylglycerides, pegoxol 7 stearate, purified water


Questions?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST


SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC Montgomery, AL 36117

Relabeled By: Preferred Pharmaceuticals Inc.