Label: CLOTRIMAZOLE cream

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 11, 2011

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

  • Active ingredient

    Clotrimazole 50mg

  • Purpose

    Vaginal antifungal/external vulvar antifungal

  • Keep Out of Reach of Children

    If swallowed, get medical help or contact a Poison Control Center right away.

  • Uses

    Treats vaginal yeast (candida) infections

    Relieves external vulvar itching and irritation associated with a yeast infection

  • Warnings

    For vaginal or external vulvar use only.

    Do not use:

    ° If you have abdominal pain, fever, or a foul smelling vaginal discharge.

    Contact your doctor immediately.

    ° In children less than 12 years of age.

    Ask a doctor before use if you have:

    ° vaginal or vulvar itching and discomfort for the first time. If you have had a doctor diagnose a vaginal yeast infection before and have the same symptoms now, use this cream as directed for 7 days in a row.

    ° symptoms that return within 2 months or infections that do not clear up easily with proper treatment. You could be pregnant, or there could be a serious underlying medical cause for your infections, including diabetes or a damaged immune system (including damage from infection from HIV - the virus that causes AIDS). Please read enclosed educational pamphlet.

    When using this product do not use tampons.

    Stop use and ask a doctor if:

    symptoms do not get better in 3 days or infection isn't gone in 7 days. You may have a condition other than a yeast infection.

    If pregnant or breast-feeding, ask a health professional before use.

  • Directions

    ° before using this product, read the enclosed pamphlet

    ° fill the applicator and insert one applicatorful of cream into the vagina, preferably at bedtime. Repeat this procedure 7 days in a row. Throw applicator away after use.

    ° for relief of external vulvar itching, squeeze a small amount of cream onto your finger and gently spread the cream onto the irritated area of the vulva. Use once or twice a day for up to 7 days as needed to relieve external vulvar itching. The cream should not be used for vulvar itching due to causes other than a yeast infection.

  • 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

    ° safety sealed: the tube opening should be sealed. If seal has been punctured or is not visible, do not use the product.

    Questions? 1-800-432-8534 (select option #2) between 9 am and 4 pm EST, Monday-Friday.

  • Inactive ingredients

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

  • Package/Label Principal Display Panel

    Clotrimazoled 1%

  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-935(NDC:0472-0220)
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE50 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECYL STEARATE (UNII: K6F16QGO28)  
    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:21695-935-4545 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07416507/16/1993
    Labeler - Rebel Distributors Corp. (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp.118802834RELABEL, REPACK