Label: CANESTEN V- clotrimazol cream
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Contains inactivated NDC Code(s)
NDC Code(s): 69772-200-01 - Packager: GENESIS IMPORTS & EXPORTS LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: New Drug Application
Drug Label Information
Updated December 28, 2017
If you are a consumer or patient please visit this version.
- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- USER SAFETY WARNINGS
- WARNINGS
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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
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
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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:
- VAGINA CREAM:INSERT ONE APPLICATOTFUL OF CREAM INTO TEH VAGINA AT BEDTIME FOR 3 DAYS IN A ROW. TROW APPLICATOR AWAY AFTER USE.
- 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
- CHILDREN UNDER 12 YEARS OF AGE : ASK A DOCTOR
- BEFORE US
EINF THIS PRODUCT READ THE ENCLOSED EDUCATIONAL BROCHURE FOR COMPLETE DIRECTIONS AND INFORMATION
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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
- PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CANESTEN V
clotrimazol creamProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69772-200 Route of Administration VAGINAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CLOTRIMAZOLE (UNII: G07GZ97H65) (CLOTRIMAZOLE - UNII:G07GZ97H65) CLOTRIMAZOLE 2 g in 100 g Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NDC:69772-200-01 1 in 1 CARTON 05/17/2016 1 21 g in 1 TUBE, WITH APPLICATOR; Type 1: Convenience Kit of Co-Package Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date NDA NDA021143 05/17/2016 Labeler - GENESIS IMPORTS & EXPORTS LLC (078760958) Registrant - TERESA CECENA (078760958) Establishment Name Address ID/FEI Business Operations GENESIS IMPORTS & EXPORTS LLC 078760958 relabel(69772-200) Establishment Name Address ID/FEI Business Operations G.P. Grenzach produktions gmbh 332090930 sterilize(69772-200) Establishment Name Address ID/FEI Business Operations Grenzach Produktions GmbH 342326972 api manufacture(69772-200) Establishment Name Address ID/FEI Business Operations BAYER DE MEXICO SA DE CV 588165709 manufacture(69772-200)
