Otc - Active Ingredient
ACTIVE INGREDIENTS
CLOTRIMAZOLE 2%
Canesten
FDA Label NDC 69772-200
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Genesis Imports & Exports Llc for the product Canesten (NDC 69772-200). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding otc - active ingredient, otc - purpose, user safety warnings, warnings, otc - ask doctor, otc - stop use, otc - pregnancy or breast feeding, otc - keep out of reach of children, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Otc - 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
Otc - 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
Otc - 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 .
Otc - Pregnancy Or Breast Feeding
IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH PROFESSIONAL BEFORE USE
Otc - 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:
- 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
Indications & Usage
OTHER INFORMATION
- TO OPEN: UNSCREW CAP, USE POINED END ON CAP TO PUNCTURE SEAL
- 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
DO NOT USE IF CARTON IS OPENED
Inactive Ingredient
Banzyl alcohol
Cetostearyl alcohol
cetyl esters wax
octydocanol
polysorbate 60
water
sorbitan monostearate
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