FDA.reportPublic FDA data

HYDROCORTISONE

Manufacturer
PHARMACY CHOICE INC
Effective date
2026-02-08
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:37:37

Label at a glance#

ProductCLOTRIMAZOLE 1%
Active ingredientCLOTRIMAZOLE
Label structure11 sections

Indications and uses

cures most athlete's foot, jock itch and ringworm relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Dosage and administration

When practical, clean area with mild soap and warm water and rinse thoroughly. Geny dry by pating or bloting with toiet tissue or soft clotibefore applying. Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day. Chidren under i2 years of age:Consult a doctor

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Clotrimazole 1%

Purpose

OTC - PURPOSE SECTION

Antifungal

Uses

OTC - WHEN USING SECTION

cures most athlete's foot, jock itch and ringworm
relieves itching, burning, cracking, scaling and discomfort which accompany these conditions

Directions

INDICATIONS & USAGE SECTION

When practical, clean area with mild soap and warm water and rinse thoroughly. Geny dry by pating or bloting with toiet tissue or soft clotibefore applying. Adults and children 12 years and older: Apply externally to the affected area up to 6 times a day.
Chidren under i2 years of age:Consult a doctor

Warnings

WARNINGS SECTION

For external use only

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

When using this product

avoid contact with eyes.

Stop use and ask a doctor if

OTC - STOP USE SECTION

irritation occurs
there is no improvement within 4 weeks (for athlete's foot or ringworm) or 2 weeks (for jock itch).

Do not use for diaper rash

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Other information

OTHER SAFETY INFORMATION

store between 20° - 25°C (68° - 77°F)
see carton or tube crimp for lot number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Glyceryl Monostearate,Polyoxyl lauryl ether, Mineral Oil, Stearic acid, Glycerin EthylParaben, Petrolatum, Purified water

DOSAGE & ADMINISTRATION SECTION

1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
309367clotrimazole 1 % Topical CreamPSN3
309367clotrimazole 10 MG/ML Topical CreamSCD3
309367clotrimazole 1 % Topical CreamSY3

DailyMed Pharmacologic Classes#

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

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
Data codeCode 128X004UM4W59Pharmacy Choice_01.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
b64d2752-34ef-378a-1f4f-8bff32b0d1aeProduct name420250626
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
cb7783e0-feaa-7e56-fb3b-d43b6efa77c9Product name220250121
4d56e8eb-d741-d4a5-de3f-2bab1af75a60Product name720220608
626d7260-31b5-4412-84fd-579746adb6b3Product name120210513
8a011600-5e61-4c59-ab7b-54ab658a3b71Product name220181127
a919621a-248d-3c7a-1084-9f9ce286fdfdProduct name220181009
e7d5a174-836b-a0af-b014-cb0826c69ddcProduct name220181004
fcce390d-6460-4701-87cf-940d8800a1c3Product name220180212
f31c883b-7ebf-1c60-f3b6-4ba41e8ff7a6Product name220151106
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1Product name220150218
02657a3f-1489-66ea-f740-5ab9524e57d7Product name120140508
26f3d783-2cc1-4327-e77d-71804cf675a2Product name120140508
36fdc54c-bbeb-981e-8a53-4d768e283892Product name120140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
61e59a42-186b-9f4b-aec3-fb49a6debc31Product name120140508
705740e1-dee5-2610-c5a3-4c59cd9d62afProduct name120140508
7bdc4804-3832-c0df-e519-72b6d47c9792Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
abaf203f-619e-f265-559f-8c81af5cb1c2Product name120140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0Product name120140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278Product name120140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fdProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
f5395dd2-4395-d8c6-3477-8c2d4a2f951cProduct name120140508
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
87228-1010-1CLOTRIMAZOLE 1%28.4 g in 1 TUBECREAM28.43
87228-1010-5CLOTRIMAZOLE 1%5 in 1 CARTONCREAM53

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
87228-101087228-1010-1, 87228-1010-5

Ingredients#

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

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

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
CLOTRIMAZOLEG07GZ97H65ACTIB
PETROLATUM4T6H12BN9UIACT
STEARIC ACID4ELV7Z65APIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
MINERAL OILT5L8T28FGPIACT
ETHYLPARABEN14255EXE39IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22025-11-17monthly-update2026-06-03 17:40:01

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
CLOTRIMAZOLE 1%CLOTRIMAZOLEPHARMACY CHOICE INC43852cfb-6d28-e54f-e063-6394a90aa0902026-02-08WarningsExact identifier
ndc (package): 87228-1010-5
ndc (package): 87228-1010-1
ndc (product): 87228-1010
ndc11 (package): 87228101001
ndc11 (package): 87228101005
spl id: 4a5bbe68-ad72-23b5-e063-6394a90a73e9
spl set id: 43852cfb-6d28-e54f-e063-6394a90aa090

Reported adverse events (FAERS/openFDA)#

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