CLOTRIMAZOLE- clotrimazole cream 
Preferred Pharmaceuticals, Inc.

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Clotrimazole

Drug Facts

Active ingredientsPurpose

Clotrimazole USP 1% (50 mg in each applicatorful)

Vaginal antifungal

Clotrimazole USP 1% (external cream)

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 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:
o
vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
o
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

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

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

Questions or comments?

call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

Relabeled By: Preferred Pharmaceuticals Inc.

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Cures Most Vaginal Yeast Infections
7 Day Treatment

7 Day Vaginal Cream

Clotrimazole Vaginal Cream USP (1%)
Vaginal Antifungal

NDC 68788-9665-4

One 45 g (1.5 oz) Tube Of Clotrimazole Vaginal Cream USP (1%)
& 1 Reusable Applicator

Educational Brochure Enclosed

Clotrimazole 7 Vaginal Cream
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-9665(NDC:51672-2003)
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole1 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol (UNII: LKG8494WBH)  
cetostearyl alcohol (UNII: 2DMT128M1S)  
cetyl esters wax (UNII: D072FFP9GU)  
octyldodecanol (UNII: 461N1O614Y)  
polysorbate 60 (UNII: CAL22UVI4M)  
water (UNII: 059QF0KO0R)  
sorbitan monostearate (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68788-9665-41 in 1 CARTON08/05/2013
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07264108/05/2013
Labeler - Preferred Pharmaceuticals, Inc. (791119022)
Registrant - Preferred Pharmaceuticals, Inc. (791119022)
Establishment
NameAddressID/FEIBusiness Operations
Preferred Pharmaceuticals, Inc.791119022RELABEL(68788-9665)

Revised: 4/2024
Document Id: f47a49f0-66ea-4f6e-ae2c-4d0dd0fc7c51
Set id: 624827d6-dbf8-4f3d-a8c0-c92474cad7de
Version: 7
Effective Time: 20240405
 
Preferred Pharmaceuticals, Inc.