CLOTRIMAZOLE- clotrimazole cream 
QUALITY CHOICE (Chain Drug Marketing Association)

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Clotrimazole Vaginal Cream, USP

Drug Facts

Active ingredients

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

Clotrimazole USP, 1% (external cream)

Purpose

Vaginal antifungal

Vaginal antifungal

Uses

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


Other information

Inactive ingredients

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

Questions?

Call 1-800-935-2362 Monday-Friday 9AM-5PM EST

Principal display panel

Educational Pamphlet Enclosed

7-Day Treatment

Clotrimazole

Vaginal Cream USP, 1%

Vaginal Antifungal

Cures Most Vaginal Yeast Infections

One 45g (1.59 OZ) Tube of Vaginal Cream (1%) and 1 Reusable Applicator (7-Day Therapy

Distributed by C.D.M.A., Inc.

43157 W 9 Mile Rd

Novi, MI 48375

www.qualitychoice.com

Package label

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

QUALITY CHOICE Vaginal Cream USP 1% with applicator

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-259
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE10 mg  in 1 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)  
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:63868-259-151 in 1 CARTON10/15/2014
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416510/15/2014
Labeler - QUALITY CHOICE (Chain Drug Marketing Association) (011920774)

Revised: 10/2020
Document Id: 3b68ab09-cc58-4718-ada6-07b3ad877ef5
Set id: cd3b71ad-eda6-43ed-8b7c-e75354f8610c
Version: 9
Effective Time: 20201026
 
QUALITY CHOICE (Chain Drug Marketing Association)