CANESTEN V (CLOTRIMAZOL) CREAM [GENESIS IMPORTS & EXPORTS LLC]

CANESTEN V (CLOTRIMAZOL) CREAM [GENESIS IMPORTS & EXPORTS LLC]
PDF | XML

NDC 69772-200-01
Set ID 33102ed2-6885-2eb3-e054-00144ff8d46c
Category HUMAN OTC DRUG LABEL
Packager GENESIS IMPORTS & EXPORTS LLC
Generic Name
Product Class Azole Antifungal
Product Number
Application Number NDA021143
  • ACTIVE INGREDIENT

    ACTIVE INGREDIENTS

    CLOTRIMAZOLE 2%

  • PURPOSE

    PURPOSE

    Vaginal Antifungal

  • USER SAFETY WARNINGS

    USE

    • TREATS VAGINAL YEAST INFECTIONS
    • RELIEVES EXTERNAL ITCHING AND IRRITATION DUE TO A VAGINAL YEAST INFECTION
  • WARNINGS

    WARNINGS

    FOR VAGINAL USE ONLY

    DPO NOT USE IF YOU HAVE NEVER HAD VAGINAL YEAST INFECTION DIAGNOSED BY

    A DOCTOR

  • ASK DOCTOR

    Ask A Doctor before if you have

    • Vaginal itching and discomfort for the first time
    • lower abdominal, back or shoulder pain, fever,chillis, nausea, vomiying, or foul-smelling vaginal discharge. You may have a more serious condition.
    • Vaginal yeast infections often ( such as once a mont h or 3 in 6 month). You can be pregnat or have a serious underlying medical cause for your sy mptoms, including, inclyding diabetes or a weakened immune system.
    • been exposed to the human immunodefiency virus (HIV) that causes AIDS
  • STOP USE

    STOP USE A ND ASK A DOCTOR IF

    • SYMPTOMS DO NOT GE T BETTER IN 3 DAYS
    • SYMPTOMS LAST MORE THAN 7 DAYS
    • DO YOU GET A RUSH OR HIVE, ABDOMINAL PAIN, FEVER , CHILLS, NAUSEA, VOMITING, OR A FOU L-SMELLING VAGINA L DISCHARGE .
  • PREGNANCY OR BREAST FEEDING

    IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE

  • KEEP OUT OF REACH OF CHILDREN

    KEEP OUT OF CHILDREN, IF SWALLOWED, GET MEDICAL HELP OR CONTACT A POISON CONTROL CENTER RIGHT A WAY

  • DOSAGE & ADMINISTRATION

    DIRECTION

    • BEFORE US EINF THIS PRODUCT READ THE ENCLOSED EDUCATIONAL BROCHURE FOR COMPLETE DIRECTIONS AND INFORMATION
      • ADULTS AND CHILDREN 12 YEARS OF AGE AND OVER:
    1. VAGINA CREAM:INSERT ONE APPLICATOTFUL OF CREAM INTO TEH VAGINA AT BEDTIME FOR 3 DAYS IN A ROW. TROW APPLICATOR AWAY AFTER USE.
    2. EXTERNAL USE: CREAM :USE THE SAME TUBE OF CREAM IF YOU HAVE ICHING AND IRRITATION ON THE SKIN OUTSIDE THE VAGINA. SQUEEZE SMALL AMOUNT OF CREAM ONTO YOUR FINGERTIP. APPLY TO ICHY, IRRITATED SKIN OUTSIDE THE VAGINA.. USE 2 TIMES DAULY FOR UP TP 7 DAY AS NEEDED
    3. CHILDREN UNDER 12 YEARS OF AGE : ASK A DOCTOR

  • INDICATIONS & USAGE

    OTHER INFORMATION

    • TO OPEN: UNSCREW CAP, USE POINED END ON CAP TO PUNCTURE SEAL

    DO NOT USE IF CARTON IS OPENED

    • SAFETY SEALED: THE TUBE OPENING SHOULD BE SEALED. IF THE SEAL HAS BEEN PUNCTURED OR IS NOT BISIBLE, DO NOY USE THE PRODUCT
    • STORE BETWEEN 20 TO 25 C (68 TO 77 F)
    • SEE FLAP OF CARTON OR CRIMP OF TUBE DOR LOT NUMBER AND EXPIRATION DATE
  • INACTIVE INGREDIENT

    Banzyl alcohol

    Cetostearyl alcohol

    cetyl esters wax

    octydocanol

    polysorbate 60

    water

    sorbitan monostearate

  • PRINCIPAL DISPLAY PANEL

    CANESTEN V

  • INGREDIENTS AND APPEARANCE
    CANESTEN  V
    clotrimazol cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-200
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE2 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    POLYSORBATE 60 (UNII: CAL22UVI4M)  
    BENZYL ALCOHOL (UNII: LKG8494WBH)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    CETYL ESTERS WAX (UNII: D072FFP9GU)  
    OCTYLDODECANOL (UNII: 461N1O614Y)  
    WATER (UNII: 059QF0KO0R)  
    SORBITAN MONOSTEARATE (UNII: NVZ4I0H58X)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69772-200-011 in 1 CARTON05/17/2016
    121 g in 1 TUBE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02114305/17/2016
    Labeler - GENESIS IMPORTS & EXPORTS LLC (078760958)
    Registrant - TERESA CECENA (078760958)
    Establishment
    NameAddressID/FEIBusiness Operations
    GENESIS IMPORTS & EXPORTS LLC078760958relabel(69772-200)
    Establishment
    NameAddressID/FEIBusiness Operations
    G.P. Grenzach produktions gmbh332090930sterilize(69772-200)
    Establishment
    NameAddressID/FEIBusiness Operations
    Grenzach Produktions GmbH342326972api manufacture(69772-200)
    Establishment
    NameAddressID/FEIBusiness Operations
    BAYER DE MEXICO SA DE CV588165709manufacture(69772-200)

Related Drugs