FDA.reportPublic FDA data

Corticol-Aloe

Manufacturer
MENPER DISTRIBUTORS INC.
Effective date
2021-08-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:41:50

Label at a glance#

ProductCorticol-Aloe
Active ingredientHYDROCORTISONE
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose

Anti-itch

INDICATIONS & USAGE SECTION

Uses

  • temproarily relieves itching associated with minor skin irritations, inflammation and rashes due to:
  • eczema
  • psoriasis
  • poison ivy, oak, sumac
  • insect bites
  • detergents
  • jewlery
  • cosmetics
  • soaps
  • seborrheic dermatitis
  • temporarily relieves extranal anal and genital itching
  • other uses of this product should only be under the advice and supervision of a doctor

WARNINGS SECTION

Warnings

For external use only.

Do not use

  • in the genital area if you have a vaginal discharg. Consult a doctor.
  • for the treatment of diaper rash. Consult a doctor

When using this product

  • avoid contact with the eyes
  • do not use more than directed unless told to do so by a doctor
  • do not put directly into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

  • condition worsen, symptoms persist for more than 7 days or clear up and occur again within a few days, and do not begin use of any other hydrocortisone product unless you have asked a doctor
  • rectal bleeding occurs

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • for itchin of skin irritiation, inflammation and rashes:
  • adults and children 2 years of agea and older: apply to affected area not more than 3 to 4 times daily
  • children under 2 years of age: ask a doctor
  • for external anal and genital itching, adults
  • when practical, clean the affected area with mild soap and warm water and rinse thouroghly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply to affected area not more than 3 to 4 times daily
  • children under 12 years of age: ask a doctor   

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe barbadensis leaf juice, beeswax, clacium acetate, cetearyl alcohol, glycerin, maltodextrin, mehtylparaben, mineral oil, propylparaben, sodium cetearyl sulfate, sodium lauryl sulfate, water, white petrolatum

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

corticolcorticol

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN1
106258hydrocortisone 10 MG/ML Topical CreamSCD1
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY1
106258hydrocortisone 1 % Topical CreamSY1
106258hydrocortisone 1 GM per 100 GM Topical CreamSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
15bd4439-874a-4934-9954-248e5455d460Product name120260310
9962b773-9f2e-22cc-0032-535e48ac417bProduct name320250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2Product name120250325
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
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
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
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
fe21f3fd-a378-0654-1972-db3c3b64470eProduct name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
53145-430-282023-07-28C16284748780-10191ceaa-6b5d-198a-e063-dbdaa90aec3ec9f49a26-c7b7-4886-9a44-ea6982a37862

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
53145-430-28Corticol-Aloe1 in 1 PACKAGECREAM11
53145-430-28Corticol-Aloe28 g in 1 TUBECREAM281

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
53145-430CORTICOL-ALOE (HYDROCORTISONE) CREAM [MENPER DISTRIBUTORS INC.]1Legacy NDC, 2 package rows20210810_c9f49a26-c7b7-4886-9a44-ea6982a37862.zip

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
53145-43053145-430-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SYNTHETIC BEESWAX08MNR5YE2RIACT
CALCIUM ACETATEY882YXF34XIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
GLYCERINPDC6A3C0OXIACT
MALTODEXTRIN7CVR7L4A2DIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PROPYLPARABENZ8IX2SC1OHIACT
SODIUM CETOSTEARYL SULFATE7ZBS06BH4BIACT
SODIUM LAURYL SULFATE368GB5141JIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT

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
8b0a5d5f-6228-484e-af02-755bfa23bf56c9f49a26-c7b7-4886-9a44-ea6982a378622021-08-09WarningsExact identifier
spl id: 8b0a5d5f-6228-484e-af02-755bfa23bf56
spl set id: c9f49a26-c7b7-4886-9a44-ea6982a37862

Reported adverse events (FAERS/openFDA)#

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