CLOTRIMAZOLE- clotrimazole cream 
Strategic Sourcing Services LLC

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Clotrimazole Vaginal Cream, USP

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

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 1-833-358-6431 Monday to Friday 9am to 7pm EST

Principal display panel

clotrimazole

Vaginal Cream, USP 1% • Vaginal Antifungal (with 1 Reusable Applicator)

Cures most vaginal yeast infections

7-day therapy / 7- day treatment

One 1.59 OZ (45g) TUBE OF VAGINAL CREAM (1%)

AND 1 REUSABLE PLASTIC APPLICATOR (7-DAY THERAPY

Distributed by McKesson Corp.,

via Strategic Sourcing Services LLC,

Memphis, TN 38141

www.sunmarkbrand.com

Package label

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

SUNMARK Vaginal Cream with Reusable Applicator

CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49348-793
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)  
OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
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:49348-793-761 in 1 CARTON07/19/1993
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416507/19/1993
Labeler - Strategic Sourcing Services LLC (116956644)

Revised: 10/2022
Document Id: 05ab3ed5-f375-4c2d-92fe-467144c3ddb0
Set id: de3b6b64-dfa5-4abd-ba43-4ab59b4c2284
Version: 10
Effective Time: 20221013
 
Strategic Sourcing Services LLC