CLOTRIMAZOLE- clotrimazole cream 
Actavis Pharma, Inc.

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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

  • 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 (1-800-222-1222) 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 7 days in a row. Wash applicator after each 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 at room temperature between 2° and 30°C (36° to 86°F)
  • see end flaps of carton and tube for lot number and expiration date
  • Tamper-evident: Safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.

Inactive ingredients

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

Questions?

1-800-432-8534 between 9 am and 4 pm EST, Monday-Friday.

Principal Display Panel

Actavis

NDC 0472-0220-63

Compare to the active ingredient
in Gyne-Lotrimin® Vaginal Cream*

Clotrimazole
Vaginal Cream, USP 1%

Vaginal Antifungal
Cures Most Vaginal Yeast Infections
1 Reusable Applicator (7-Day Therapy) 
7-Day Treatment

One 45 g (1.5 OZ) Tube of Vaginal Cream (1%) and
1 Reusable Applicator (7-Day Therapy)

Educational Pamphlet Enclosed

Clotrimazole Vaginal Cream
CLOTRIMAZOLE 
clotrimazole cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0472-0220
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)  
OCTYLDODECANOL (UNII: 461N1O614Y)  
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:0472-0220-631 in 1 CARTON07/01/200302/28/2023
145 g in 1 TUBE; Type 0: Not a Combination Product
2NDC:0472-0220-411 in 1 CARTON07/01/200307/31/2022
245 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA07416507/01/200302/28/2023
Labeler - Actavis Pharma, Inc. (119723554)

Revised: 9/2022
 
Actavis Pharma, Inc.