CANESTEN

Manufacturer
GENESIS IMPORTS & EXPORTS LLC | TERESA CECENA | G.P. Grenzach produktions gmbh | Grenzach Produktions GmbH | BAYER DE MEXICO SA DE CV
Effective date
2017-12-28
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 22:53:45

Label at a glance#

ProductCANESTEN V
Active ingredientCLOTRIMAZOLE
Label structure12 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE INGREDIENTS

CLOTRIMAZOLE 2%

OTC - PURPOSE SECTION

PURPOSE

Vaginal Antifungal

USER SAFETY WARNINGS SECTION

USE

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

WARNINGS SECTION

WARNINGS

FOR VAGINAL USE ONLY

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

A DOCTOR

OTC - ASK DOCTOR SECTION

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, incly ding diabetes or a weakened immune system.
  • been exposed to the human immunodefiency virus (HIV) that causes AIDS

OTC - STOP USE SECTION

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 SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

DOSAGE & ADMINISTRATION SECTION

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 SECTION

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 SECTION

Banzyl alcohol

Cetostearyl alcohol

cetyl esters wax

octydocanol

polysorbate 60

water

sorbitan monostearate

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CANESTEN VCANESTEN V

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199603clotrimazole 2 % Vaginal CreamPSN3
199603clotrimazole 20 MG/ML Vaginal CreamSCD3
199603clotrimazole 2 % Vaginal CreamSY3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
CLOTRIMAZOLE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
9869efd7-d6dd-0665-5b67-53adbe6ef15eProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69772-200-012020-01-31C16284748780-19d75b9d0-6f82-f424-e053-dadaa90a57ce33102ed2-6885-2eb3-e054-00144ff8d46c

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69772-200-01CANESTENV21 g in 1 TUBE, WITH APPLICATORCREAM213
69772-200-01CANESTENV1 in 1 CARTONCREAM13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69772-200CANESTEN V (CLOTRIMAZOL) CREAM [GENESIS IMPORTS & EXPORTS LLC]3Legacy NDC, 2 package rows20171228_33102ed2-6885-2eb3-e054-00144ff8d46c.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 10 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69772-20069772-200-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Source Document#

Source XML · Source PDF

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
N021143-001TRIVAGIZOLE 3CLOTRIMAZOLE2%CREAM / VAGINAL2000-04-12

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-1284e616aacf4f…
2026-08-18 06:07:402026-07N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-1231067a03dcf5…
2025-08-23 18:47 UTC2025-08N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-126a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-1203ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-122680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-125bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-1279d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-121e350fbaab3a…
2024-05-31 18:47 UTC2024-05N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-128072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-125c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-125d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-124b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-1274a2ff9319b5…
2022-03-09 01:35 UTC2022-03N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-1287673890dc5c…
2021-03-12 10:30 UTC2021-03N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-125aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-128869cabd3fbd…
2020-11-12 02:37 UTC2020-11N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12c0c555d07b60…
2019-12-14 00:12 UTC2019-12N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-123f01610625f2…
2019-09-15 20:21 UTC2019-09N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12b00525d2431f…
2019-07-19 19:46 UTC2019-07N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-126a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-121c564ffb4f44…
2023-12-20 04:57 UTC2023-12N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-129b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-123f0d92c62455…
2023-05-13 08:27 UTC2023-05N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12053a50430f4f…
2023-01-26 05:58 UTC2023-01N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-123bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-123a93d1ddd44b…
2022-10-28 04:53 UTC2022-10N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12f41ea6bd6efb…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
616b57f0-5634-7772-e053-2a91aa0affd133102ed2-6885-2eb3-e054-00144ff8d46c2017-12-28WarningsExact identifier
spl id: 616b57f0-5634-7772-e053-2a91aa0affd1
spl set id: 33102ed2-6885-2eb3-e054-00144ff8d46c

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.