Clotrimazole Vaginal Cream

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SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1% (50 mg in each applicatorful)

Clotrimazole 1% (external cream)

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

• treats vaginal yeast infections
• relieves external itching and irritation associated due to a vaginal yeast infection

Warnings

WARNINGS SECTION

For vaginal use only

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• 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

OTC - WHEN USING SECTION

• 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

OTC - STOP USE SECTION

• 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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

• 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

OTHER SAFETY 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

INACTIVE INGREDIENT SECTION

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

Questions?

OTC - QUESTIONS SECTION

1-800-432-8534 between 9 am and 4 pm EST, Monday- Friday.

Principal Display Panel

PACKAGE LABEL.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

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Products#

Every source-derived product name is available through these pages.

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• Clotrimazole
• BENZYL ALCOHOL
• CETOSTEARYL ALCOHOL
• CETYL ESTERS WAX
• OCTYLDODECANOL
• POLYSORBATE 60
• WATER
• SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
• SORBITAN MONOSTEARATE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 9 matching rows.

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Observed Orange Book product history#

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Product history page 1 of 2 · 44 observed states.

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