FDA.reportPublic FDA data

Hydrocortisone Cream 1% with Aloe

Manufacturer
Sun Pharmaceutical Industries, Inc. | GOPALDAS VISRAM AND COMPANY LIMITED
Effective date
2025-06-16
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:03:12

Label at a glance#

ProductHydrocortisone with Aloe
Active ingredientHYDROCORTISONE
Label structure12 sections

Indications and uses

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

Dosage and administration

for itching of skin irritation, inflammation, and rashes adults and children 2 years of age 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 thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before ...

Storage and handling

do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal store at room temperature 68-77°F (20°-25°C) see crimp of tube or carton for Lot Number and Expiry Date

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

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

When using this product

OTC - WHEN USING SECTION

  • avoid contact with 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

OTC - STOP USE SECTION

  • condition worsens, 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • for itching of skin irritation, inflammation, and rashes
  • adults and children 2 years of age 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 thoroughly
  • 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

Other information

STORAGE AND HANDLING SECTION

  • do not use if seal on the tube is damaged or is not visible. To open, unscrew cap, pull tab to remove foil seal
  • store at room temperature 68-77°F (20°-25°C)
  • see crimp of tube or carton for Lot Number and Expiry Date

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe Vera Extract, Cetostearyl Alcohol, Glyceryl Monostearate SE, Kathon CG, Propylene Glycol, Purified Water, Stearic Acid, Trolamine, White Petrolatum

Questions or Comments?

OTC - QUESTIONS SECTION

Call 1-866-923-4914

SPL UNCLASSIFIED SECTION

Distributed by:
Ohm Laboratories Inc.
New Brunswick, NJ 08901

Manufactured in India

MH/DRUGS/28-KD/503

PRINCIPAL DISPLAY PANEL - 28.4 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

MAXIMUM STRENGTH

Hydrocortisone Cream 1%

Soothing Aloe Cream

NET WT 1 oz (28.4 g)

CartonCarton

PRINCIPAL DISPLAY PANEL - 28.4 g Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN2
106258hydrocortisone 10 MG/ML Topical CreamSCD2
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY2
106258hydrocortisone 1 % Topical CreamSY2
106258hydrocortisone 1 GM per 100 GM Topical CreamSY2

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
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
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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
51672-5330-1Hydrocortisonewith Aloe1 in 1 CARTONCREAM12
51672-5330-1Hydrocortisonewith Aloe14.2 g in 1 TUBECREAM14.22
51672-5330-2Hydrocortisonewith Aloe28.4 g in 1 TUBECREAM28.42
51672-5330-2Hydrocortisonewith Aloe1 in 1 CARTONCREAM12
51672-5330-3Hydrocortisonewith Aloe1 in 1 CARTONCREAM12
51672-5330-3Hydrocortisonewith Aloe60 g in 1 TUBECREAM602

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
51672-5330-1GM - Gram51672-5330d55a9c62-93c2-4ea1-85c7-9f017497becd12025-05-14
51672-5330-2GM - Gram51672-5330584276fc-3edd-421b-b681-8eee6e7b2ac112025-05-14
51672-5330-3GM - Gram51672-53301521f1f7-8a24-48ed-8928-eceea98c688212026-02-05

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
51672-533051672-5330-1, 51672-5330-2, 51672-5330-3

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
STEARYL ALCOHOL2KR89I4H1YIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
TROLAMINE9O3K93S3TKIACT
STEARIC ACID4ELV7Z65APIACT
ALOE VERA LEAFZY81Z83H0XIACT
HYDROCORTISONEWI4X0X7BPJACTIB
CETOSTEARYL ALCOHOL2DMT128M1SIACT
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE15O9QS218WIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
WATER059QF0KO0RIACT

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
Hydrocortisone with AloeHYDROCORTISONE CREAM 1%Sun Pharmaceutical Industries, Inc.312ddc8d-100e-cfac-e063-6294a90acd092025-06-16WarningsExact identifier
ndc (package): 51672-5330-3
ndc (package): 51672-5330-1
ndc (package): 51672-5330-2
ndc (product): 51672-5330
ndc11 (package): 51672533002
ndc11 (package): 51672533001
ndc11 (package): 51672533003
spl id: 37b256dc-b651-8a1c-e063-6394a90ab04c
spl set id: 312ddc8d-100e-cfac-e063-6294a90acd09

Reported adverse events (FAERS/openFDA)#

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