GYNE-LOTRIMIN 3- clotrimazole cream 
Bayer HealthCare LLC.

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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

Principal Display Panel - 21g Tube Carton
GYNE-LOTRIMIN 3 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11523-0771
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE2 g  in 100 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)  
SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:11523-0771-11 in 1 CARTON01/01/200211/01/2015
121 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA02114301/01/200211/01/2015
Labeler - Bayer HealthCare LLC. (112117283)

Revised: 11/2017
 
Bayer HealthCare LLC.