Gyne-Lotrimin 3

Dosage form: cream
Ingredients: CLOTRIMAZOLE 2g in 100g
Labeler: MSD Consumer Care, Inc.
NDC Code: 11523-0771

Gyne-Lotrimin 3® Vaginal Cream

Drug Facts

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

Uses
  • treats vaginal yeast infections
  • relieves external itching 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 the 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
  • store between 20° to 25°C (68° to 77°F)
  • see end panel of carton and tube crimp for lot number and expiration date
  • tamper-evident: do not use if seal embossed with "S" over tube opening is missing, open or broken

Inactive ingredients

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

Questions or comments?

If you have questions or need more information on this product, call toll free 1-800-317-2165 between 8:00 AM and 5:00 PM Central Standard Time, Monday through Friday.

© Copyright & Distributed by
Schering-Plough HealthCare Products, Inc., Memphis, TN 38151 USA.

PRINCIPAL DISPLAY PANEL - 21g Tube Carton

Cures most vaginal yeast infections

Gyne-Lotrimin3®
3-Day
Treatment

Clotrimazole Vaginal Cream (2%)
Vaginal Antifungal

Vaginal Cream

One 21g (0.74 oz) Tube of Clotrimazole Vaginal Cream (2%)
and 3 Disposable Applicators

Educational
Brochure
Enclosed

GYNE-LOTRIMIN 3 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0771
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 Description
1NDC:11523-0771-11 TUBE, WITH APPLICATOR (TUBE) in 1 CARTON
121 g in 1 TUBE, WITH APPLICATOR
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02114301/01/2002
Labeler - MSD Consumer Care, Inc. (968091715)

Revised: 02/2012
 
MSD Consumer Care, Inc.

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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