Clotrimazole Vaginal Cream, USP

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Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole, USP 1% (50 mg in each applicatorful)

Clotrimazole, USP 1% (external cream)

Purpose

OTC - PURPOSE SECTION

Vaginal antifungal

Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

Do not use

SPL UNCLASSIFIED SECTION

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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

• 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)
• before using any medication, read all label directions. Keep carton, it contain important information.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal display panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

7-Day Treatment

Clotrimazole

Vaginal Cream, USP 1%

VAGINAL ANTIFUNGAL

Clotrimazole Vaginal Cream Can Kill The Yeast That May Cause Vaginal Infection

Cures Most Vaginal Yeast Infections

g (OZ) Tube

Tube of Vaginal Cream (1%) and 1 Reusable Applicator

Distributed by: CDMA, Inc.

Novi, MI 48375

Package label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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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

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Ingredients#

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Product history page 1 of 2 · 43 observed states.

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