FDA.reportPublic FDA data

Hydrocortisone Cream 1/2% with Aloe

Manufacturer
Sun Pharmaceutical Industries, Inc. | GOPALDAS VISRAM AND COMPANY LIMITED
Effective date
2026-08-16
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-08-26 01:01:43

Label at a glance#

ProductHydrocortisone with Aloe
Active ingredientHYDROCORTISONE
Label structure11 sections

Indications and uses

temporarily relieves of itching associated with minor skin irritations, inflammation, and rashes due to eczema insect bites cosmetics psoriasis detergents soaps poison ivy, oak, sumac jewelry seborrheic dermatitis 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 0.5%

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
    • cosmetics
    • psoriasis
    • detergents
    • soaps
    • poison ivy, oak, sumac
    • jewelry
    • seborrheic dermatitis
  • 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?

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

Hydrocortisone Cream 1/2%

NET WT 1 oz (28.4 g)

CartonCarton

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130351672533526GTIN-13: 0351672533526
EAN-13: 0351672533526
GTIN-12: 351672533526
UPC-A: 351672533526
GTIN storage (14 digits): 00351672533526		HYDROCORTISONE ALOE 0.5_Carton-2.jpg

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
51672-533551672-5335-2

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
HYDROCORTISONEWI4X0X7BPJACTIB
PROPYLENE GLYCOL6DC9Q167V3IACT
WHITE PETROLATUMB6E5W8RQJ4IACT
TROLAMINE9O3K93S3TKIACT
STEARIC ACID4ELV7Z65APIACT
ALOE VERA LEAFZY81Z83H0XIACT
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 1/2%Sun Pharmaceutical Industries, Inc.59337940-c9be-58af-e063-6394a90abe132026-08-16WarningsExact identifier
ndc (package): 51672-5335-2
ndc (product): 51672-5335
ndc11 (package): 51672533502
spl id: 5933787d-8cc1-5959-e063-6394a90a9f80
spl set id: 59337940-c9be-58af-e063-6394a90abe13

Reported adverse events (FAERS/openFDA)#

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