Equaline Tioconazole 1 TIOCONAZOLE UNITED NATURAL FOODS, INC. DBA UNFI FDA Approved Use • treats vaginal yeast infections
FunFoxMeds box
Substance Tioconazole
Route
VAGINAL
Applications
ANDA075915
Package NDC

Drug Facts

Composition & Profile

Active Ingredients
Active ingredient (in each applicator) Tioconazole 300 mg (6.5%)
Inactive Ingredients
Inactive ingredients butylated hydroxyanisole magnesium aluminum silicate white petrolatum
Strengths
300 mg
Quantities
1 dose
Treats Conditions
Use Treats Vaginal Yeast Infections
Pill Appearance
Color: brown

Identifiers & Packaging

Container Type UNKNOWN
All Product Codes
UNII
S57Y5X1117
Packaging

Principal Display Panel EQUALINE ® COMPARE TO Monistat ® 1 active ingredient 1-DOSE TREATMENT Tioconazole-1 tioconazole ointment 6.5% vaginal antifungal • 1 Pre-filled applicator • Cures most vaginal yeast infections • Odorless formula 1 DOSE TREATMENT WITH 1 PRE-FILLED APPLICATOR Educational brochure enclosed NET WT 0.16 OZ (4.6g) tioconazole-1-image

Package Descriptions
  • Principal Display Panel EQUALINE ® COMPARE TO Monistat ® 1 active ingredient 1-DOSE TREATMENT Tioconazole-1 tioconazole ointment 6.5% vaginal antifungal • 1 Pre-filled applicator • Cures most vaginal yeast infections • Odorless formula 1 DOSE TREATMENT WITH 1 PRE-FILLED APPLICATOR Educational brochure enclosed NET WT 0.16 OZ (4.6g) tioconazole-1-image

Overview

Use • treats vaginal yeast infections

Indications & Usage

Use • treats vaginal yeast infections

Dosage & Administration

Directions • before using this product, read the enclosed brochure and instructions on printed packet for complete directions and information • adults and children 12 years of age and over: • open the printed packet just before use and remove purple cap • insert entire contents of applicator into the vagina at bedtime. Throw applicator away after use. • children under 12 years of age: ask a doctor

Warnings & Precautions
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 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 disease (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 (1-800-222-1222).
Purpose

Purpose Vaginal antifungal

Do Not Use

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

When Using

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 disease (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 & Ask a Doctor

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

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 (1-800-222-1222).

Storage & Handling

Other information • this product is a 1-dose treatment. Most women do not experience complete relief of their symptoms in just one day. Most women experience some relief within one day and complete relief of symptoms within 7 days. • if you have questions about vaginal yeast infections, consult your doctor • store at 20 ° -25 ° C (68 ° -77 ° F) • see end flap of carton for lot number and expiration date

Questions

Questions or comments? 1-855-423-2630


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