CANESTEN V- clotrimazol cream 
GENESIS IMPORTS & EXPORTS LLC

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ACTIVE INGREDIENTS

CLOTRIMAZOLE 2%

PURPOSE

Vaginal Antifungal

USE

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

STOP USE A ND ASK A DOCTOR IF

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

  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

DO NOT USE IF CARTON IS OPENED

Banzyl alcohol

Cetostearyl alcohol

cetyl esters wax

octydocanol

polysorbate 60

water

sorbitan monostearate

CANESTEN V

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)

Revised: 12/2017
Document Id: 616b57f0-5634-7772-e053-2a91aa0affd1
Set id: 33102ed2-6885-2eb3-e054-00144ff8d46c
Version: 3
Effective Time: 20171228
 
GENESIS IMPORTS & EXPORTS LLC