sunmark

Label at a glance#

Contacts and useful links#

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients	Purpose
Clotrimazole USP 2% (100 mg in each applicatorful)	Vaginal Antifungal
Clotrimazole USP 2% (external cream)	Vaginal Antifungal

Use

INDICATIONS & USAGE SECTION

• treats vaginal yeast infections
• relieves external itching and irritation 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 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 3 days in a row. Throw applicator away after 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

STORAGE AND HANDLING SECTION

• To open: unscrew cap, use pointed end on cap to puncture seal
• do not use if carton is opened
• safety sealed:the tube opening should be sealed. If the seal has been punctured or is not visible, do not use the product.
• store between 20° to 25°C (68° to 77°F)
• see flap of carton or crimp of tube for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or comments?

OTC - QUESTIONS SECTION

Call toll-free, 1-888-827-6222,for our 24 hour automated response system.

SPL UNCLASSIFIED SECTION

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

sunmark ^®

clotrimazole 3

Clotrimazole Vaginal Cream USP (2%)
Vaginal Antifungal

Cures Most Vaginal Yeast Infections

3 DAY TREATMENT

One 21 g (0.74 oz) Tube Of Clotrimazole Vaginal Cream USP (2%)
& 3 Disposable Applicators

DailyMed RxNorm Mappings#

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DailyMed Socrata Ingredients#

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

• sunmark Clotrimazole 3
• Clotrimazole
• BENZYL ALCOHOL
• CETOSTEARYL ALCOHOL
• CETYL ESTERS WAX
• OCTYLDODECANOL
• POLYSORBATE 60
• WATER
• SORBITAN MONOSTEARATE

NDC Codes#

Ingredients#

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DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

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Inactive ingredient links page 1 of 1 · 12 matching rows.

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Orange Book application contexts page 1 of 1 · 1 matching rows.

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Current product rows page 1 of 1 · 1 matching rows.

Observed Orange Book product history#

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Product history page 1 of 2 · 43 observed states.

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Reported adverse events (FAERS/openFDA)#

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