Your browser does not support JavaScript! SUNMARK CLOTRIMAZOLE 3 (CLOTRIMAZOLE) CREAM [MCKESSON]
DailyMed Logo Header image

Daily Med

Current Medication Information

Options

RxNorm Names

SUNMARK CLOTRIMAZOLE 3 (clotrimazole) cream
[McKesson]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL New Drug Application
Drug Label Sections

Drug Facts

Active ingredientsPurpose
Clotrimazole USP 2% (100 mg in each applicatorful)Vaginal Antifungal
Clotrimazole USP 2% (external cream)Vaginal Antifungal

Use

  • 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 toll-free, 1-888-827-6222, for our 24 hour automated response system.

Distributed by McKesson
One Post Street
San Francisco, CA 94104

PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

sunmark®

clotrimazole 3

Clotrimazole Vaginal Cream USP (2%)
Vaginal Antifungal

Cures Most Vaginal Yeast Infections

3 DAY TREATMENT

One 21 g (0.74 oz) Tube Of Clotrimazole Vaginal Cream USP (2%)
& 3 Disposable Applicators

Principal Display Panel - 21 g Tube Carton
SUNMARK   CLOTRIMAZOLE 3
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:49348-379
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (Clotrimazole) Clotrimazole2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
benzyl alcohol 
cetostearyl alcohol 
cetyl esters wax 
octyldodecanol 
polysorbate 60 
water 
sorbitan monostearate 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:49348-379-541 in 1 CARTON
121 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02114304/12/2000
Labeler - McKesson (177667227)
Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(49348-379)

Revised: 2/2013
 
McKesson

Visit The National Library of Medicine Copyright, Privacy, Accessibility
U.S. National Library of Medicine, 8600 Rockville Pike, Bethesda, MD 20894
National Institutes of Health, Health & Human Services