Clotrimazole Cream 1%

Manufacturer
SOLA Pharmaceuticals
Effective date
2022-07-05
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:50:04

Label at a glance#

ProductClotrimazole Cream 1%
Active ingredientCLOTRIMAZOLE
Label structure9 sections

Dosage and administration

Clean the affected area and dry thoroughly. Apply a layer of cream over the affected area twice daily morning and night or as directed by doctor. Supervise children in the use of this product. For athlete's foot pay special attention to the spaces between 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. For jock itch use...

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Usage

INDICATIONS & USAGE SECTION

  • For External treatment of most athlete's foot (tinea pedis), jock ithc (tinea crusis), ringworm (tinea corporis).
  • Relieves itching, cracking scaling irritation and chafing associated with these conditions.

Warnings

WARNINGS SECTION

Do not use on children under 2 years of age unless directed by a doctor.

For external use only.

Avoid contact with eyes.

If irritation occurs or if there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch), discontinue use and consult a doctor.

Keep this and all drugs out of the reach of children. In case of accidental ingestion, seek professional assistance or contact a Poison Control Center right away.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep this and all drugs our of the reach of children. In case of accidental ingestion, seek profesional assistance or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Clean the affected area and dry thoroughly. Apply a layer of cream over the affected area twice daily morning and night or as directed by doctor.
  • Supervise children in the use of this product.
  • For athlete's foot pay special attention to the spaces between 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.
  • For jock itch use daily for 2 weeks.
  • If condition persist longer consult a doctor.
  • This product is not effective on scalp or nails.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Cetomacragol 1000, Cetostearyl alcohol, Liquid paraffin, Methyl Paraben, Propyl paraben, Propylene glycol, Purified water, White soft paraffin.

Other Information

OTHER SAFETY INFORMATION

  • Store between 20ºC and 25ºC (68ºF and 77ºF)

Questions or comments?

Call 1-866-747-7365

Package Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Questions or comments?

Call 1-866-747-7365

Manufactured for : SOLA Pharmaceuticals

Baton Rouge, LA 70810


Store in a dry, cool place


For Comments or Questions, call 866-747-7365

Clotrimazole 1% Cream

NDC 70512-100-30


Qty: 28.4g

Clotrimazole AF boxClotrimazole AF boxClotrimazole generic boxClotrimazole generic boxClotrimazole tubeClotrimazole tube

NDC 70512-100-15

QTY 14.2

15gm box15gm box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN4
309367clotrimazole 10 MG/ML Topical CreamSCD4
309367clotrimazole 1 % Topical CreamSY4

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70512-100-152024-01-30C16284748780-11030e365-4dfd-111a-e063-dadaa90a10e2Clotrimazole Cream 1% - Antifungal Cream
70512-100-302024-01-30C16284748780-11030e365-4dfd-111a-e063-dadaa90a10e2Clotrimazole Cream 1% - Antifungal Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70512-100-15Clotrimazole Cream 1%14.2 g in 1 TUBECREAM14.24
70512-100-15Clotrimazole Cream 1%1 in 1 CARTONCREAM14
70512-100-30Clotrimazole Cream 1%1 in 1 CARTONCREAM14
70512-100-30Clotrimazole Cream 1%30 g in 1 TUBECREAM304

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70512-100CLOTRIMAZOLE CREAM 1% CREAM [SOLA PHARMACEUTICALS]4Legacy NDC, 4 package rows20220706_a3424c66-68ee-0631-e053-2995a90a3e7a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70512-100-30GM - Gram70512-100e484bd68-218c-447c-9be9-6882a915bb7812020-08-06

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
70512-10070512-100-30, 70512-100-15

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Source Document#

Source XML · Source PDF

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
e314d3ba-c23e-39c0-e053-2995a90a7ca9a3424c66-68ee-0631-e053-2995a90a3e7a2022-07-05WarningsExact identifier
spl id: e314d3ba-c23e-39c0-e053-2995a90a7ca9
spl set id: a3424c66-68ee-0631-e053-2995a90a3e7a

Reported adverse events (FAERS/openFDA)#

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