Clotrimazole

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Contacts and useful links#

PhonePoison Help1-800-222-1222

PhoneLabel contact1-877-753-3935

Websitewww.h2-pharma.comwww.h2-pharma.com

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Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

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

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

SPL UNCLASSIFIED 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 - 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:
  • ovaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
  • oexternal 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 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 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
• before using any medication, read all label directions. Keep carton, it contains 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?

OTC - QUESTIONS SECTION

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

SPL UNCLASSIFIED SECTION

Distributed by: H2-Pharma, LLC
Montgomery, AL 36117
www.h2-pharma.com

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68788-8330-4

Clotrimazole
Vaginal Cream, USP 1%

Vaginal Antifungal
(with 1 Reusable Applicator)

Cures most vaginal yeast infections
7-day therapy / 7-day treatment
Educational pamphlet enclosed

Net wt. 1.59 oz (45 g) tube

7 day vaginal cream with 1 reusable applicator

H² pharma

Relabeled By: Preferred Pharmaceuticals Inc.

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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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