FDA Label for Clotrimazole
View Indications, Usage & Precautions
- OTHER
- ACTIVE INGREDIENTS
- PURPOSE
- USES
- WARNINGS
- OTC - DO NOT USE
- ASK A DOCTOR BEFORE USE IF YOU HAVE
- WHEN USING THIS PRODUCT
- STOP USE AND ASK A DOCTOR IF
- OTC - PREGNANCY OR BREAST FEEDING
- OTC - KEEP OUT OF REACH OF CHILDREN
- DIRECTIONS
- OTHER INFORMATION
- INACTIVE INGREDIENTS
- QUESTIONS?
- PRINCIPAL DISPLAY PANEL
Clotrimazole Product Label
The following document was submitted to the FDA by the labeler of this product Preferred Pharmaceuticals, 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.
Other
Drug Facts
Active Ingredients
Clotrimazole 1% (50 mg in each applicatorful)
Clotrimazole 1% (external cream)
Purpose
Vaginal antifungal
Vaginal antifungal
Uses
• treats vaginal yeast infections• relieves external itching and irritation associated due to a vaginal yeast infection
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
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 a 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 (1-800-222-1222) right away.
Directions
• before using this product, read the enclosed educational brochure for complete directions and information• adults and children 12 years of age and over:• vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.• external cream: 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. Use 2 times daily for up to 7 days as needed.• children under 12 years of age: ask a doctor
Other Information
• store at room temperature between 2° and 30°C (36° to 86°F)• see end flaps of carton and tube for lot number and expiration date• Tamper-evident: Safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.
Inactive Ingredients
benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate
Questions?
1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.
Principal Display Panel
45g tube - 68788-0169-4
Compare to the active ingredient
in Gyne-Lotrimin® Vaginal Cream*
Clotrimazole
Vaginal Cream, USP 1%
Vaginal Antifungal
Cures Most Vaginal Yeast Infections
1 Reusable Applicator (7-Day Therapy)
7-Day Treatment
ONE 45 g (1.5 OZ) Tube of Vaginal Cream (1%) and
1 Reusable Applicator (7-Day Therapy)
Educational Pamphlet Enclosed
* Please review the disclaimer below.