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CANESTEN V

Medically reviewed on Dec 28, 2017

Dosage form: cream
Ingredients: CLOTRIMAZOLE 2g in 100g
Labeler: GENESIS IMPORTS & EXPORTS LLC
NDC Code: 69772-200

ACTIVE INGREDIENTS

CLOTRIMAZOLE 2%

PURPOSE

Vaginal Antifungal

USE

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

WARNINGS

FOR VAGINAL USE ONLY

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

A 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 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 .

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

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

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

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

Banzyl alcohol

Cetostearyl alcohol

cetyl esters wax

octydocanol

polysorbate 60

water

sorbitan monostearate

CANESTEN  V
clotrimazol cream
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69772-200
Route of AdministrationVAGINALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CLOTRIMAZOLE (CLOTRIMAZOLE) CLOTRIMAZOLE2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
POLYSORBATE 60 
BENZYL ALCOHOL 
CETOSTEARYL ALCOHOL 
CETYL ESTERS WAX 
OCTYLDODECANOL 
WATER 
SORBITAN MONOSTEARATE 
Packaging
#Item CodePackage Description
1NDC:69772-200-011 TUBE, WITH APPLICATOR in 1 CARTON
121 g in 1 TUBE, WITH APPLICATOR
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/FEIOperations
GENESIS IMPORTS & EXPORTS LLC078760958relabel(69772-200)
Establishment
NameAddressID/FEIOperations
G.P. Grenzach produktions gmbh332090930sterilize(69772-200)
Establishment
NameAddressID/FEIOperations
Grenzach Produktions GmbH342326972api manufacture(69772-200)
Establishment
NameAddressID/FEIOperations
BAYER DE MEXICO SA DE CV588165709manufacture(69772-200)

 
GENESIS IMPORTS & EXPORTS LLC

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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