Label: CLOTRIMAZOLE cream

  • NDC Code(s): 0472-0220-41, 0472-0220-63
  • Packager: Actavis Pharma, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 23, 2022

If you are a consumer or patient please visit this version.

  • 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
  • INGREDIENTS AND APPEARANCE
    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)