Clotrimazole

Drug Facts

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

Uses

For vaginal use only

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

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

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

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.

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

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

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

call 1-866-923-4914

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

Product: 53002-9080

NDC: 53002-9080-1 45 g in a TUBE / 1 in a CARTON

CLOTRIMAZOLE
clotrimazole cream

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65)	CLOTRIMAZOLE	1 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:53002-9080-1	1 in 1 CARTON	06/01/2019	12/31/2022
1		45 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
ANDA	ANDA072641	12/04/1995	12/31/2022

Labeler - RPK Pharmaceuticals, Inc. (147096275)

Name	Address	ID/FEI	Business Operations
Establishment
RPK Pharmaceuticals, Inc.		147096275	RELABEL(53002-9080)

Revised: 9/2023

Document Id: ff1162b6-0ef5-4ac3-9704-0d1fa69ead95

Set id: 375a57fe-206c-41fc-90a4-a96f8c0676fe

Version: 5

Effective Time: 20230905

RPK Pharmaceuticals, Inc.