FDA.reportPublic FDA data

CVS Clotrimazole 1% Solution Maximum Strength

Manufacturer
CVS Pharmacy | Natureplex LLC
Effective date
2022-11-01
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:51:21

Label at a glance#

ProductCVS Clotrimazole Maximum Strength
Active ingredientCLOTRIMAZOLE
Label structure10 sections

Indications and uses

For the effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Dosage and administration

clean the affected area and dry thoroughly use brush to apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor supervise children in the use of this product for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily for athlete's foot and ringworm, use daily for 4 weeks...

Storage and handling

store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON BOTTLE IS PUNCTURED OR MISSING

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

INDICATIONS & USAGE SECTION

  • For the effective treatment of most athlete's foot (tinea pedis) and ringworm (tinea corporis)

Warnings

WARNINGS SECTION

For external use only

Avoid contact with eyes

Do not use

OTC - DO NOT USE SECTION

  • on children under 2 years of age unless directed by a doctor

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • irritation occurs
  • there is no improvement within 4 weeks

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: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

  • clean the affected area and dry thoroughly
  • use brush to apply a thin layer of product over affected area twice daily (morning and night) or as directed by a doctor
  • supervise children in the use of this product
  • for athlete's foot, pay special attention to spaces between the toes, wear well-fitting, ventilated shoes and change shoes and socks at least once daily
  • for athlete's foot and ringworm, use daily for 4 weeks
  • if condition persists longer, consult a doctor
  • this product is not effective on the scalp or nails

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON BOTTLE IS PUNCTURED OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

glycine soja (soybean) oil, melaleuca alternifolia (tea tree) leaf oil, mentha piperita (peppermint) oil

SPL UNCLASSIFIED SECTION

Distributed by: CVS Pharmacy, Inc.
One CVS Drive, Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health®

Compare to the active
ingredient in Lotrimin®AF**

NDC 69842-866-01

MAXIMUM STRENGTH
Clotrimazole 1%
ANTIFUNGAL SOLUTION

  • Kills most athlete's foot
  • Effectively relieves itching,
    burning, cracking & scaling
  • Proprietary blend of tea tree
    & peppermint oils
  • Paraben free

Package Contains
One Bottle

0.5 FL OZ (15 mL)

PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton
PRINCIPAL DISPLAY PANEL - 15 mL Bottle Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309370clotrimazole 1 % Topical SolutionPSN4
309370clotrimazole 10 MG/ML Topical SolutionSCD4
309370clotrimazole 1 % Topical SolutionSY4

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
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-866-012025-01-30C16284748780-12cef2736-7f04-d83d-e063-dadaa90ab31fCVS Clotrimazole 1% Solution Maximum Strength

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-866-01CVS Clotrimazole Maximum Strength1 in 1 CARTONSOLUTION14
69842-866-01CVS Clotrimazole Maximum Strength15 mL in 1 BOTTLE, WITH APPLICATORSOLUTION154

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-866CVS CLOTRIMAZOLE MAXIMUM STRENGTH (CLOTRIMAZOLE) SOLUTION [CVS PHARMACY]4Legacy NDC, 2 package rows20221104_c4feae92-e7a0-4abc-aa4e-72b8ae00f501.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-866-01ML - Milliliter69842-866be7d4af8-7c2f-404f-b568-cef1ff76a07012018-07-03

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-86669842-866-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 4 matching rows.

Name, UNII, Kind table
NameUNIIKind
CLOTRIMAZOLEG07GZ97H65ACTIB
SOYBEAN OIL241ATL177AIACT
PEPPERMINT OILAV092KU4JHIACT
TEA TREE OILVIF565UC2GIACT

Source Document#

Source XML

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
3cc572bc-ed77-43f1-a68f-007c98b78e08c4feae92-e7a0-4abc-aa4e-72b8ae00f5012022-11-01WarningsExact identifier
spl id: 3cc572bc-ed77-43f1-a68f-007c98b78e08
spl set id: c4feae92-e7a0-4abc-aa4e-72b8ae00f501

Reported adverse events (FAERS/openFDA)#

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