SPL UNCLASSIFIED SECTION.


Drug Facts.

DOSAGE & ADMINISTRATION SECTION.


Directions. before using this product, read the enclosed educational brochure for complete directions and informationadults and children 12 years of age and over:vaginal cream: insert one applicatorful of cream into the vagina at bedtime for days in 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 small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use times daily for up to days as needed. children under 12 years of age: ask doctor 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 days in 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 small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use times daily for up to days as needed. vaginal cream: insert one applicatorful of cream into the vagina at bedtime for days in 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 small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use times daily for up to days as needed.. children under 12 years of age: ask doctor.

INACTIVE INGREDIENT SECTION.


Inactive ingredients. benzyl alcohol, cetostearyl alcohol, cetyl esters wax, 2-octyldodecanol, polysorbate 60, purified water, sodium phosphate monobasic, sorbitan monostearate.

INDICATIONS & USAGE SECTION.


Uses. treats vaginal yeast infections relieves external itching and irritation due to vaginal yeast infection. treats vaginal yeast infections relieves external itching and irritation due to vaginal yeast infection.

OTHER SAFETY INFORMATION.


Other information. to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to usedo not use if foil seal on tube opening is broken or missingdo not purchase if carton is openstore at room temperature 20o to 25oC (68o to 77oF) [see USP Controlled Room temperature] excursions permitted to 15o 30oC (59o 86oF)before using any medication, read all label directions. Keep carton, it contains important 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 20o to 25oC (68o to 77oF) [see USP Controlled Room temperature] excursions permitted to 15o 30oC (59o 86oF). before using any medication, read all label directions. Keep carton, it contains important information.

OTC - ACTIVE INGREDIENT SECTION.


Active ingredients Clotrimazole, USP 1% (50 mg in each applicatorful)Clotrimazole USP, 1% (external cream).

OTC - ASK DOCTOR SECTION.


Ask 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 more serious condition.vaginal yeast infections often (such as once month or in months). You could be pregnant, or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system.been exposed to the human immunodeficiency virus (HIV) that causes AIDS. 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 more serious condition.. vaginal yeast infections often (such as once month or in months). You could be pregnant, or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system.. been exposed to the human immunodeficiency virus (HIV) that causes AIDS.

OTC - DO NOT USE SECTION.


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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION.


Keep out of reach of children.. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.

OTC - PREGNANCY OR BREAST FEEDING SECTION.


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

OTC - PURPOSE SECTION.


Purpose. Vaginal antifungalVaginal antifungal.

OTC - QUESTIONS SECTION.


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

OTC - STOP USE SECTION.


Stop use and ask doctor if. symptoms do not get better in dayssymptoms last more than days.you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. symptoms do not get better in days. symptoms last more than days.. you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.

OTC - WHEN USING SECTION.


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 intercoursemild increase in vaginal burning, itching or irritation may occurif you do not get complete relief, ask doctor before using another 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 doctor before using another product.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


Principal display panel. Clotrimazole 7VAGINAL CREAM, USP 1%VAGINAL ANTIFUNGAL 7-DAY TREATMENTCures most vaginal yeast infectionsEducational pamphlet enclosed ONE 1.59 OZ (45g) TUBE OF VAGINAL CREAM (1%) 1 REUSABLE APPLICATOR (7-DAY THEARPY)DISTRIBUTED BY: WALGREEN CO.200 WILMOT RD., DEERFIELD, IL 6005. Cures most vaginal yeast infections. Educational pamphlet enclosed.

WARNINGS SECTION.


Warnings. For vaginal use only Do not use. if you have never had vaginal yeast infection diagnosed by doctor Ask 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 more serious condition.vaginal yeast infections often (such as once month or in months). You could be pregnant, or have serious underlying medical cause for your symptoms, including diabetes or weakened immune system.been exposed to the human immunodeficiency virus (HIV) that causes AIDS. 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 more serious condition.. vaginal yeast infections often (such as once month or in months). You could be pregnant, or have serious underlying medical cause for your symptoms, including diabetes or 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 intercoursemild increase in vaginal burning, itching or irritation may occurif you do not get complete relief, ask doctor before using another 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 doctor before using another product Stop use and ask doctor if. symptoms do not get better in dayssymptoms last more than days.you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. symptoms do not get better in days. symptoms last more than days.. you get rash or hives, abdominal pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge. If pregnant or breast-feeding,. ask health professional before use.. Keep out of reach of children.. If swallowed, get medical help or contact Poison Control Center (1-800-222-1222) right away.