Walgreens

Manufacturer
Walgreen Company | Sun Pharma Canada Inc.
Effective date
2025-07-08
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:06:48

Label at a glance#

ProductWalgreens Clotrimazole 3
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

treats vaginal yeast infections relieves external itching and irritation due to a vaginal yeast infection

Dosage and administration

before using this product read the enclosed educational brochure for complete directions and information adults and children 12 years of age and over: vaginal cream: insert one applicatorful of cream into the vagina at bedtime for 3 days in a row. Throw applicator away after use. external cream: use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of ...

Storage and handling

to open: unscrew cap, use pointed 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 visible, do not use the product. store between 20° to 25°C (68° to 77°F) see flap of carton or crimp of tube for lot number and expiration date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Clotrimazole USP 2% (100 mg in each applicatorful)Vaginal antifungal
Clotrimazole USP 2% (external cream)Vaginal antifungal

Uses

INDICATIONS & USAGE SECTION

  • treats vaginal yeast infections
  • relieves external itching and irritation due to a vaginal yeast infection

Warnings

WARNINGS SECTION

For vaginal use only

OTC - DO NOT USE SECTION

Do not use if you have never had a vaginal yeast infection diagnosed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • vaginal itching and discomfort for the first time
  • lower abdominal, back or shoulder pain, fever, chills, nausea, vomiting, or foul-smelling vaginal discharge.
    You may have a more serious condition.
  • vaginal yeast infections often (such as once a month or 3 in 6 months). You could be pregnant or have a serious underlying medical cause for your symptoms, including diabetes or a weakened immune system.
  • been exposed to the human immunodeficiency virus (HIV) that causes AIDS

When using this product

OTC - WHEN USING SECTION

  • do not use tampons, douches, spermicides, or other vaginal products. Condoms and diaphragms may be damaged and fail to prevent pregnancy or sexually transmitted diseases (STDs).
  • do not have vaginal intercourse
  • mild increase in vaginal burning, itching or irritation may occur
  • if you do not get complete relief ask a doctor before using another product

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • symptoms do not get better in 3 days
  • symptoms last more than 7 days
  • you get a rash or hives, abdominal pain, fever, chills, nausea, vomiting, or a foul-smelling vaginal 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 reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • before using this product read the enclosed educational brochure for complete directions and information
  • adults and children 12 years of age and over:
    • vaginal cream:insert one applicatorful of cream into the vagina at bedtime for 3 days in a row. Throw applicator away after use.
    • external cream:use the same tube of cream if you have itching and irritation on the skin outside the vagina. Squeeze a small amount of cream onto your fingertip. Apply to itchy, irritated skin outside the vagina. Use 2 times daily for up to 7 days as needed.
  • children under 12 years of age: ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • to open: unscrew cap, use pointed 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 visible, do not use the product.
  • store between 20° to 25°C (68° to 77°F)
  • see flap of carton or crimp of tube for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

2-octyldodecanol, benzyl alcohol, cetostearyl alcohol, cetyl esters wax, polysorbate-60, purified water, and sorbitan monostearate

Questions or comments?

OTC - QUESTIONS SECTION

call 1-866-923-4914

SPL UNCLASSIFIED SECTION

DISTRIBUTED BY: WALGREEN CO.
DEERFIELD, IL 60015

PRINCIPAL DISPLAY PANEL - 21 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Walgreens

NDC 0363-2062-01

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
199603clotrimazole 2 % Vaginal CreamPSN5
199603clotrimazole 20 MG/ML Vaginal CreamSCD5
199603clotrimazole 2 % Vaginal CreamSY5

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
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-2062-01Walgreens Clotrimazole 31 in 1 CARTONCREAM15
0363-2062-01Walgreens Clotrimazole 321 g in 1 TUBE, WITH APPLICATORCREAM215

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ClotrimazoleACTIVE INGREDIENTG07GZ97H651
ClotrimazoleACTIVE MOIETYG07GZ97H651
benzyl alcoholINACTIVE INGREDIENTLKG8494WBH1
cetostearyl alcoholINACTIVE INGREDIENT2DMT128M1S1
cetyl esters waxINACTIVE INGREDIENTD072FFP9GU1
octyldodecanolINACTIVE INGREDIENT461N1O614Y1
polysorbate 60INACTIVE INGREDIENTCAL22UVI4M1
sorbitan monostearateINACTIVE INGREDIENTNVZ4I0H58X1
waterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-20620363-2062-01

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

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 12 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
cetyl esters waxCETYL ESTERS WAXD072FFP9GUCREAM / VAGINAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
octyldodecanolOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
octyldodecanolOCTYLDODECANOL461N1O614YCREAM / VAGINAL13.5 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
polysorbate 60POLYSORBATE 60CAL22UVI4MCREAM / VAGINAL200 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
sorbitan monostearateSORBITAN MONOSTEARATENVZ4I0H58XCREAM / VAGINAL100 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetostearyl alcoholCETOSTEARYL ALCOHOL2DMT128M1SCREAM / VAGINAL6 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
cetyl esters waxCETYL ESTERS WAXD072FFP9GUCREAM / VAGINAL3 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates
benzyl alcoholBENZYL ALCOHOLLKG8494WBHCREAM / VAGINAL1 %w/wExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09N021143-001TRIVAGIZOLE 32%CREAM / VAGINAL2000-04-12c2088c7a36db…
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…

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
Walgreens Clotrimazole 3CLOTRIMAZOLEWalgreen Company7fafdebd-b117-4a6b-a499-a4d3ac086ab92025-07-08WarningsExact identifier
ndc (package): 0363-2062-01
ndc (product): 0363-2062
ndc11 (package): 00363206201
spl id: 39725af6-cc4c-a7f1-e063-6394a90accb6
spl set id: 7fafdebd-b117-4a6b-a499-a4d3ac086ab9

Reported adverse events (FAERS/openFDA)#

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