FDA Label for Miconazole 1 Combination Pack
View Indications, Usage & Precautions
- PURPOSE
- USES
- WARNINGS
- DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- ASK A DOCTOR OR PHARMACIST BEFORE USE IF YOU ARE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- IF PREGNANT OR BREAST-FEEDING,
- KEEP OUT OF REACH OF CHILDREN.
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Miconazole 1 Combination Pack Product Label
The following document was submitted to the FDA by the labeler of this product Cvs Pharmacy, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Purpose
Miconazole nitrate 1200 mg (in vaginal insert) Vaginal antifungal
Miconazole nitrate 2% (external cream) Vaginal antifungal
Uses
- treats vaginal yeast infections
- relieves external itching and irritation due to a 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 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
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.
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:
▪ vaginal insert: with the applicator, place the vaginal insert into the vagina. Throw applicator away after use.
▪ external cream: squeeze a small amount of cream onto your fingertip. Apply the cream onto the 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
- do not use if printed sealed pouch or sealed vaginal insert blister is torn, open or incompletely sealed
- do not use if seal over tube opening has been punctured
- do not purchase if carton is open
- store at 20°-25°C (68°-77°F)
- this is a 1-dose treatment. Most women do not get complete relief of their symptoms in just 1 day. Most women get some improvement in 1 day and complete relief by 7 days.
Inactive Ingredients
vaginal insert: gelatin, glycerin, lecithin, mineral oil, titanium dioxide, white petrolatum
external cream: benzoic acid, cetyl alcohol, isopropyl myristate, polysorbate 60, potassium hydroxide, propylene glycol, purified water, stearyl alcohol
Questions?
call toll-free 877-666-4782
Principal Display Panel
Miconazole 1
Miconazole Nitrate Vaginal Insert (1200 mg)
Miconazole Nitrate Cream (2%)
VAGINAL ANTIFUNGAL | Yeast infection relief
- Cures most vaginal yeast infections
- Relieves associated external itching & irritation
Net Wt. 0.32oz (9g) tube
1 Vaginal Softgel Insert + Applicator
* Please review the disclaimer below.