CVS PHARMACY CLOTRIMAZOLE 3- clotrimazole cream

United States - English - NLM (National Library of Medicine)

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Active ingredient:
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65)
Available from:
CVS Pharmacy
Administration route:
VAGINAL
Prescription type:
OTC DRUG
Therapeutic indications:
- treats vaginal yeast infections - relieves external itching and irritation due to a vaginal yeast infection
Authorization status:
New Drug Application
Authorization number:
69842-062-00

CVS PHARMACY CLOTRIMAZOLE 3- clotrimazole cream

CVS Pharmacy

----------

CVS Pharmacy

Clotrimazole 3

Drug Facts

Active ingredients

Purpose

Clotrimazole USP 2% (100 mg in

each applicatorful)

Vaginal

antifungal

Clotrimazole USP 2% (external

cream)

Vaginal

antifungal

Us es

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:

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

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, and sorbitan monostearate

Questions or comments?

call 1-866-923-4914

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

CVSHealth

Clotrimazole 3

CLOTRIMAZOLE VAGINAL CREAM USP 2%

Vaginal antifungal

Cures most vaginal yeast infections

EDUCATIONAL BROCHURE ENCLOSED

1 TUBE 21 g (0.74 OZ)

3 DISPOSABLE APPLICATORS

NDC 69842-062-00

CVS PHARMACY CLOTRIMAZOLE 3

clotrimazole cream

CVS Pharmacy

Product Information

Product T ype

HUMAN OTC DRUG

Ite m Code (Source )

NDC:6 9 8 42-0 6 2

Route of Administration

VAGINAL

Active Ingredient/Active Moiety

Ingredient Name

Basis of Strength

Stre ng th

Clo trima zo le (UNII: G0 7GZ9 7H6 5) (Clo trimazo le - UNII:G0 7GZ9 7H6 5)

Clo trima z o le

2 g in 10 0 g

Inactive Ingredients

Ingredient Name

Stre ng th

benzyl a lco ho l (UNII: LKG8 49 4WBH)

ceto stea ryl a lco ho l (UNII: 2DMT128 M1S)

cetyl esters wa x (UNII: D0 72FFP9 GU)

O CTYLDO DECANO L (UNII: 46 1N1O6 14Y)

PO LYSO RBATE 6 0 (UNII: CAL22UVI4M)

WATER (UNII: 0 59 QF0 KO0 R)

so rbita n mo no stea ra te (UNII: NVZ4I0 H58 X)

Packag ing

#

Item Code

Package Description

Marketing Start

Date

Marketing End

Date

1

NDC:6 9 8 42-0 6 2-

1 in 1 CARTON

0 8 /0 6 /20 19

1

21 g in 1 TUBE, WITH APPLICATOR; Type 0 : No t a Co mbinatio n

Pro duc t

Marketing Information

Marke ting Cate gory

Application Numbe r or Monograph Citation

Marke ting Start Date

Marke ting End Date

NDA0 21143

0 4/12/20 0 0

Labeler -

CVS Pharmacy (062312574)

Revised: 8/2019

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