Label: CLOTRIMAZOLE cream

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

Drug Label Information

Updated April 5, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • ACTIVE INGREDIENT

    Active ingredientsPurpose

    Clotrimazole USP, 1% (50 mg in each applicatorful)

    Vaginal antifungal

    Clotrimazole USP, 1% (external cream)

    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:
    o
    vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 7 days in a row. Wash applicator after each use.
    o
    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

    •
    to open tube: unscrew cap, lift tab, and pull to remove foil seal prior to use
    •
    do not use if foil seal on tube opening is broken or missing
    •
    do not purchase if carton is open
    •
    store at room temperature 20° to 25°C (68° to 77°F) [see USP Controlled Room Temperature] excursions permitted to 15°-30°C (59°-86°F)
    •
    before using any medication, read all label directions. Keep carton, it contains important information.
  • Inactive ingredients

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

  • Questions?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

  • SPL UNCLASSIFIED SECTION

    Distributed by: H2-Pharma, LLC
    Montgomery, AL 36117
    www.h2-pharma.com

    Relabeled By: Preferred Pharmaceuticals Inc.

  • PRINCIPAL DISPLAY PANEL - 45 g Tube Carton

    NDC 668788-8491-4

    Clotrimazole
    Vaginal Cream, USP 1%

    Vaginal Antifungal
    (with 1 Reusable Applicator)

    Cures most vaginal yeast infections
    7-day therapy / 7-day treatment
    Educational pamphlet enclosed

    Net wt. 1.59 oz (45 g) tube

    7 day vaginal cream with 1 reusable applicator

    H2 pharma

    Relabeled By: Preferred Pharmaceuticals Inc.

    Clotrimazole 7 Day Vaginal Cream
  • INGREDIENTS AND APPEARANCE
    CLOTRIMAZOLE 
    clotrimazole cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:68788-8491(NDC:61269-220)
    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)  
    Product Characteristics
    ColorWHITEScore    
    ShapeSize
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:68788-8491-41 in 1 CARTON07/24/2023
    145 g in 1 TUBE, WITH APPLICATOR; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07416507/24/2023
    Labeler - Preferred Pharmaceuticals Inc. (791119022)
    Registrant - Preferred Pharmaceuticals Inc. (791119022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Preferred Pharmaceuticals Inc.791119022RELABEL(68788-8491)
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