Freds
FDA Label NDC 55315-737

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Fred's, Inc. for the product Freds (NDC 55315-737). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding other, active ingredient, purpose, use, warnings, otc - do not use, ask a doctor before use if you have, otc - ask doctor/pharmacist, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Other

Drug Facts

DISTRIBUTED BY: fred's, Inc.
4300 NEW GETWELL RD,
MEMPHIS, TN 38118

Active Ingredient

Miconazole Nitrate USP 4% (200 mg in each applicatorful)

Purpose

Vaginal antifungal

Use

  • treats vaginal yeast infections

Warnings

For vaginal use only

Otc - Do Not Use

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

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

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

Otc - Keep Out Of Reach Of Children

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:
    • applicators: insert 1 applicatorful into the vagina at bedtime for 3 nights in a row. Throw applicator away after use.
    • children under 12 years of age: ask a doctor

Other Information

  • store at 20°-25°C (68°-77°F)
  • do not purchase if carton is open
  • see end flaps of carton and end of tube for lot number and expiration date
  • the tube opening should be sealed. If seal has been broken, do not use product.

Inactive Ingredients

cetyl alcohol, isopropyl myristate, polysorbate 60, polysorbate 80, potassium hydroxide, propylene glycol, purified water, sorbitan monostearate and stearyl alcohol.

Questions?

Call 1-866-923-4914

Principal Display Panel - 25 G Tube Carton

fred's
Pharmacy

Cures Most Vaginal
Yeast Infections

3 Day
Treatment

MICONAZOLE
3
Miconazole Nitrate Vaginal Cream USP (4%)
(Miconazole Nitrate 200 mg per applicator)

VAGINAL ANTIFUNGAL

ONE 0.9 oz (25 g) TUBE OF 3 DAY VAGINAL CREAM WITH 3 DISPOSABLE APPLICATORS

Consumer
Information
Leaflet Enclosed

Principal Display Panel (25 g Tube Carton)

Principal Display Panel (25 g Tube Carton)

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