APTRIMAZOLE

Manufacturer
A P J Laboratories Limited
Effective date
2013-04-27
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:35:23

Label at a glance#

ProductAPTRIMAZOLE 1.0% ANTIFUNGAL CREAM
Active ingredientCLOTRIMAZOLE
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

CLOTRIMAZOLE

OTC - PURPOSE SECTION

Antifungal

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.

INDICATIONS & USAGE SECTION

Cures most athlete's foot, jock itch, and ringworm.

Relieves itching, burning, cracking, scaling and discomfort which accompany these conditions.



Do not use:

WARNINGS SECTION

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

Avoid contact with eyes.

For athletes foot and ringworm - if irritation occurs, or if there is no improvement within 4 weeks, discontinue use and consult a doctor.

For jock itch - if irritation occurs, or if there is no improvement within two weeks, discontinue use and consult a doctor.

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.







Direction:

DOSAGE & ADMINISTRATION SECTION

Clean the affected area and dry thoroughly. Apply a layer of cream 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 toes: wear well fitting, ventilated shoes, and change shoes and socks at least once daily.

Foe athlete's foot and ringworm, use daily for 4 weeks.

For jock itch, use daily for 2 weeks.

If conditions persist longer, consult a doctor.

This product is not effective on scalp or nails.



INACTIVE INGREDIENT SECTION


PETROLATUM

LIGHT MINERAL OIL

CETOSTEARYL ALCOHOL

EDETIC ACID

CHLOROCRESOL

SODIUM PHOSPHATE, DIBASIC, ANHYDROUS

POLYSORBATE 60

CETETH-20

DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

product
product

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN1
309367clotrimazole 10 MG/ML Topical CreamSCD1
309367clotrimazole 1 % Topical CreamSY1

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
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
46084-081-312019-11-27C16284748780-19855d018-d748-cd31-e053-dbdaa90ab51ab54ff8e9-ea77-4702-8c2f-4c693df45547

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
46084-081-31APTRIMAZOLE1.0% ANTIFUNGAL CREAM15 g in 1 TUBECREAM151

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
46084-081APTRIMAZOLE 1.0% ANTIFUNGAL CREAM (CLOTRIMAZOLE) CREAM [A P J LABORATORIES LIMITED]1Legacy NDC, 1 package rows20130508_b54ff8e9-ea77-4702-8c2f-4c693df45547.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
CLOTRIMAZOLEACTIVE INGREDIENTG07GZ97H651
CLOTRIMAZOLEACTIVE MOIETYG07GZ97H651
CETETH-20INACTIVE INGREDIENTI835H2IHHX1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CHLOROCRESOLINACTIVE INGREDIENT36W53O71091
EDETIC ACIDINACTIVE INGREDIENT9G34HU7RV01
LIGHT MINERAL OILINACTIVE INGREDIENTN6K5787QVP1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
POLYSORBATE 60INACTIVE INGREDIENTCAL22UVI4M1
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSINACTIVE INGREDIENT22ADO53M6F1

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
46084-08146084-081-31

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

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 3 · 126 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / OPHTHALMIC1.4 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAVENOUS1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0GEL / TOPICAL0.1 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPPASTE / DENTAL687 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION / INTRALESIONAL28 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FFILM / SUBLINGUAL6 mgExact identifier — unii candidate
48 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULIQUID / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
18 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET / ORAL7.5 mgExact identifier — unii candidate
19 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPTABLET, EXTENDED RELEASE / ORAL1 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRAMUSCULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCAPSULE, EXTENDED RELEASE / ORAL207 mgExact identifier — unii candidate
48 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXCREAM / TOPICAL429 mgExact identifier — unii candidate
4 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSPRAY, METERED / NASAL7 mgExact identifier — unii candidate
48 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUSPENSION / AURICULAR (OTIC)NAExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1STABLET, EXTENDED RELEASE / ORAL800 mgExact identifier — unii candidate
9 equally ranked IID candidates
CETETH-20CETETH-20I835H2IHHXSOLUTION / TOPICAL2 %w/wExact identifier — unii candidate
4 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM / TOPICAL4213 mgExact identifier — unii candidate
18 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPAEROSOL, FOAM / TOPICAL240 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SOLUTION / INTRAVENOUS2460 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MCREAM / TOPICAL225 mgExact identifier — unii candidate
13 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPSUPPOSITORY / VAGINAL1464.9 mgExact identifier — unii candidate
19 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSHAMPOO / TOPICAL14.55 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR1751 mgExact identifier — unii candidate
48 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOINTMENT / TOPICAL1335 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / OPHTHALMIC1.21 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0TABLET, FILM COATED / ORAL0.2 mgExact identifier — unii candidate
13 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE / VAGINALNAExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FCREAM / TOPICAL0.36 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINSERT / INTRAOCULAR0.02 mgExact identifier — unii candidate
48 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPOIL / AURICULAR (OTIC)419 mgExact identifier — unii candidate
19 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0SUSPENSION / TOPICAL0.06 %w/vExact identifier — unii candidate
13 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSPRAY / TOPICAL1 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, EMULSION / INTRAVENOUS0.28 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCAPSULE, EXTENDED RELEASE / ORAL0.07 mgExact identifier — unii candidate
18 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MGUM, CHEWING / BUCCAL5 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / ORAL140 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION / INTRA-ARTICULAR36 mgExact identifier — unii candidate
48 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SLOTION / TOPICAL3627 mgExact identifier — unii candidate
9 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPLOTION / TOPICAL48000 mgExact identifier — unii candidate
19 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SOINTMENT / TOPICAL1.2 %w/wExact identifier — unii candidate
9 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USUPPOSITORY / VAGINAL27 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR139.2 mgExact identifier — unii candidate
48 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCAPSULE, EXTENDED RELEASE / ORAL9.43 mgExact identifier — unii candidate
9 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FAEROSOL, FOAM / TOPICAL0.09 %w/wExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLOZENGE / TRANSMUCOSAL112 mgExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FOINTMENT / TOPICAL1 mgExact identifier — unii candidate
48 equally ranked IID candidates
CHLOROCRESOLCHLOROCRESOL36W53O7109CREAM, AUGMENTED / TOPICAL0.1 %w/wExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9USOAP / TOPICAL0.85 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
EDETIC ACIDEDETIC ACID9G34HU7RV0INJECTION, SOLUTION / INTRAMUSCULAR2 mgExact identifier — unii candidate
13 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION/ DROPS / TOPICAL0.14 %w/vExact identifier — unii candidate
48 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FSOLUTION / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MOINTMENT / TOPICAL2 %w/wExact identifier — unii candidate
13 equally ranked IID candidates
LIGHT MINERAL OILLIGHT MINERAL OILN6K5787QVPCAPSULE / ORAL6 mgExact identifier — unii candidate
19 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FINJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR8 mgExact identifier — unii candidate
48 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM PHOSPHATE, DIBASIC, ANHYDROUSSODIUM PHOSPHATE, DIBASIC, ANHYDROUS22ADO53M6FLIQUID / INTRAVENOUS381 mgExact identifier — unii candidate
48 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MAEROSOL, FOAM / TOPICAL30 mgExact identifier — unii candidate
13 equally ranked IID candidates
POLYSORBATE 60POLYSORBATE 60CAL22UVI4MSUSPENSION / ORAL125 mgExact identifier — unii candidate
13 equally ranked IID candidates

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
8ef19bfe-6e70-4aed-979b-274315278c63b54ff8e9-ea77-4702-8c2f-4c693df455472013-04-27WarningsExact identifier
spl id: 8ef19bfe-6e70-4aed-979b-274315278c63
spl set id: b54ff8e9-ea77-4702-8c2f-4c693df45547

Reported adverse events (FAERS/openFDA)#

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