CLOTRIMAZOLE- clotrimazole cream 
Taro Pharmaceuticals U.S.A., Inc.

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Clotrimazole

Drug Facts

Active ingredientsPurpose
Clotrimazole USP 1% (50 mg in each applicatorful)Vaginal antifungal
Clotrimazole USP 1% (external cream)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 right away.

Directions

Other information

Inactive ingredients

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

Questions or comments?

call 1-866-923-4914

Distributed by:
Taro Pharmaceuticals U.S.A., Inc.
Hawthorne, NY 10532

PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

Cures Most Vaginal Yeast Infections
7 Day Treatment

7 Day Vaginal Cream

Clotrimazole Vaginal Cream USP (1%)
Vaginal Antifungal

One 45 g (1.5 oz) Tube Of Clotrimazole Vaginal Cream USP (1%)
& 1 Reusable Applicator

Educational Brochure Enclosed

Principal Display Panel
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51672-2003
Route of AdministrationVAGINAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Clotrimazole (UNII: G07GZ97H65) (Clotrimazole - UNII:G07GZ97H65) Clotrimazole1 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:51672-2003-61 in 1 CARTON12/04/1995
145 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07264112/04/1995
Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
Establishment
NameAddressID/FEIBusiness Operations
Taro Pharmaceuticals Inc.206263295MANUFACTURE(51672-2003)

Revised: 1/2019
Document Id: 42aa6f14-d38f-410a-9f23-811e08fea629
Set id: f7192955-8f8c-45dd-a215-8ac2c1f6444f
Version: 3
Effective Time: 20190110
 
Taro Pharmaceuticals U.S.A., Inc.