Clotrimazole: Package Insert and Label Information

CLOTRIMAZOLE- clotrimazole cream
Preferred Pharmaceuticals, Inc.

Drug Facts

Active ingredients

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

Active ingredients

Clotrimazole, USP 1% (external cream)

Purpose

Vaginal antifungal

Purpose

Vaginal antifungal

Uses

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

Warnings

For vaginal use only

Do not use

if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a 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 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

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

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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

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

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

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

Questions?

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

Principal Display Panel

Actavis

Relabeled by: Preferred Pharmaceuticals Inc.

NDC 68788-7682-04

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

Clotrimazole 7 Vaginal Cream
(click image for full-size original)
CLOTRIMAZOLE
clotrimazole cream
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:68788-7682(NDC:0472-0220)
Route of Administration VAGINAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE 10 mg in 1 g
Inactive Ingredients
Ingredient Name Strength
BENZYL ALCOHOL
CETOSTEARYL ALCOHOL
CETYL ESTERS WAX
OCTYLDODECANOL
POLYSORBATE 60
WATER
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
SORBITAN MONOSTEARATE
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:68788-7682-4 1 TUBE in 1 CARTON contains a TUBE
1 45 g in 1 TUBE This package is contained within the CARTON (68788-7682-4)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
ANDA ANDA074165 05/01/2020
Labeler — Preferred Pharmaceuticals, Inc. (791119022)
Registrant — Preferred Pharmaceuticals, Inc. (791119022)
Establishment
Name Address ID/FEI Operations
Preferred Pharmaceuticals, Inc. 791119022 RELABEL (68788-7682)

Revised: 04/2021 Preferred Pharmaceuticals, Inc.

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