Galentic Hydrocortisone Cream 1%

Manufacturer
Galentic Pharma (India) Priva Te Limited
Effective date
2013-08-07
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:36:29

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE ACETATE
Label structure11 sections

Dosage and administration

Adults and children over 2 years of age Apply evenly to affected area no more than 3 or 4 times daily. Children under 2 years of age Do not use consult a physician Adults When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly Gently dry, patting and blotting with bathroom tissue or soft cloth before applying apply externally to the area up to 6 times daily or after each bowel ...

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient                            Purpose

Hydrocortisone Acetate 1%            Antipruritic (anti-itch)

Purpose:

OTC - PURPOSE SECTION

For temporary relief of;

  • minor skin irritations

Itching and rashes due to;

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumac
  • soaps
  • detergents
  • cosmetics
  • jewelry


and for external itching of;

  •  genital
  • feminine and
  • anal itching

Warnings:

WARNINGS SECTION

For external use only

Do not use:

OTC - DO NOT USE SECTION

  • in the eyes
  • longer than 1 week unless directed by a physician
  • for diaper rash
  • if you have vaginal discharge
  • more than the recommended daily dosage unless directed by a doctor
  • in the rectum bu using fingers or any other mechanical device or applicator

Stop use and ask a physician if:

OTC - STOP USE SECTION

  • the condition persists or gets worse
  • symptoms clear up and occur again within a few days
  • you are pregnant or breast feeding

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.

Directions:

DOSAGE & ADMINISTRATION SECTION

Adults and children over 2 years of age
  • Apply evenly to affected area no more than 3 or 4 times daily.
Children under 2 years of age
  • Do not use
  • consult a physician
Adults
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry, patting and blotting with bathroom tissue or soft cloth before applying
  • apply externally to the area up to 6 times daily or after each bowel movement

Other information:

SPL UNCLASSIFIED SECTION

  • Store at 20 deg - 25 deg C (68 deg - 77 deg F)
  • Avoid excessive heat and humidity

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Cetomacrogol 1000, Cetostearyl Alcohol, Chlorocresol, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Sodium Betabisulphite, White Soft Paraffin, Water (purified)

INDICATIONS & USAGE SECTION

For temporary relief of minor skin irritations and external itching.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone 1%

Hydrocortisone Cream.jpg

HydrocortisoneHydrocortisone

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN1
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD1
1043690hydrocortisone acetate 1 % 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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
50382-010-012019-11-27C16284748780-19855d018-d6ac-cd31-e053-dbdaa90ab51aGalentic Hydrocortisone Cream 1%
50382-010-022019-11-27C16284748780-19855d018-d6ac-cd31-e053-dbdaa90ab51aGalentic Hydrocortisone Cream 1%

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50382-010-01Hydrocortisone28.3 g in 1 TUBECREAM28.31
50382-010-02Hydrocortisone425 g in 1 JARCREAM4251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50382-010HYDROCORTISONE CREAM [GALENTIC PHARMA (INDIA) PRIVA TE LIMITED]1Legacy NDC, 2 package rows20130808_eb49a81d-35d8-415c-a6a4-111eeb7125fc.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
HYDROCORTISONE ACETATEACTIVE INGREDIENT3X7931PO741
HYDROCORTISONEACTIVE MOIETYWI4X0X7BPJ1
CETETH-20INACTIVE INGREDIENTI835H2IHHX1
CETOSTEARYL ALCOHOLINACTIVE INGREDIENT2DMT128M1S1
CHLOROCRESOLINACTIVE INGREDIENT36W53O71091
EDETATE DISODIUMINACTIVE INGREDIENT7FLD91C86K1
MINERAL OILINACTIVE INGREDIENTT5L8T28FGP1
PETROLATUMINACTIVE INGREDIENT4T6H12BN9U1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
SODIUM METABISULFITEINACTIVE INGREDIENT4VON5FNS3C1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 11 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50382-01050382-010-01, 50382-010-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 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 5 · 264 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION, SUSPENSION / INTRA-ARTICULAR1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION / INTRAMUSCULAR96 mgExact identifier — unii candidate
43 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRALESIONAL0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / INTRA-ARTICULAR0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / ORAL4 mgExact identifier — unii candidate
77 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KEMULSION / OPHTHALMIC0.3 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / TOPICAL8 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3AEROSOL, METERED / RECTALNAExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM / BUCCAL1.48 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KENEMA / RECTAL60 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION, SOLUTION / INTRAMUSCULAR4000 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSHAMPOO / TOPICAL1 %w/wExact identifier — unii candidate
77 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPFILM, EXTENDED RELEASE / TRANSDERMAL34 mgExact identifier — unii candidate
30 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SSUPPOSITORY / VAGINALNAExact identifier — unii candidate
9 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION/ DROPS / OPHTHALMIC1 mgExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION / PERINEURAL0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3GEL / OPHTHALMIC0.44 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / TOPICAL4886 mgExact identifier — unii candidate
81 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPCAPSULE / ORAL120 mgExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / TOPICAL7275 mgExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION, SOLUTION / INFILTRATION0.05 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION / INTRALESIONAL0.1 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSOLUTION / ORAL432 mgExact identifier — unii candidate
77 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, FILM COATED / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT, AUGMENTED / TOPICAL81.94 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
CHLOROCRESOLCHLOROCRESOL36W53O7109CREAM / TOPICAL5 mgExact identifier — unii candidate
2 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UAEROSOL, FOAM / TOPICAL7.9 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CSOLUTION / ORAL640 mgExact identifier — unii candidate
43 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CINJECTION / INTRAVENOUS27.5 %w/vExact identifier — unii candidate
43 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
30 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KLIQUID / NASAL2 mg/1mlExact identifier — unii candidate
77 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CSYSTEM / TOPICAL0.5 mgExact identifier — unii candidate
43 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSUSPENSION / ORAL30 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3INJECTION / INTRAVENOUS16624 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KSYSTEM / IONTOPHORESIS0.1 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUPPOSITORY / VAGINAL252 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / ORAL22602 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION, CONCENTRATE / INTRAVENOUS50.33 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UCREAM, AUGMENTED / TOPICAL26 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CTABLET / RECTAL2 mgExact identifier — unii candidate
43 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / TOPICAL82 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KCREAM, AUGMENTED / TOPICAL2 mgExact identifier — unii candidate
77 equally ranked IID candidates
CETOSTEARYL ALCOHOLCETOSTEARYL ALCOHOL2DMT128M1SCREAM / TOPICAL1428 mgExact identifier — unii candidate
9 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSUSPENSION / OPHTHALMIC0.1 %w/wExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPTABLET, DELAYED RELEASE / ORAL5.67 mgExact identifier — unii candidate
30 equally ranked IID candidates
MINERAL OILMINERAL OILT5L8T28FGPSYSTEM / TOPICAL654.36 mgExact identifier — unii candidate
30 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / RECTAL90400 mgExact identifier — unii candidate
81 equally ranked IID candidates
SODIUM METABISULFITESODIUM METABISULFITE4VON5FNS3CTABLET, CHEWABLE / ORAL0.2 mgExact identifier — unii candidate
43 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KINJECTION / SOFT TISSUE0.05 %w/vExact identifier — unii candidate
77 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9UOINTMENT / AURICULAR (OTIC)NAExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, SOLUBLE / BUCCAL5 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET, DELAYED RELEASE / ORAL100 mgExact identifier — unii candidate
77 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SUSPENSION / ORAL27120 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3EMULSION / OPHTHALMIC1.5 %w/vExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CONCENTRATE / ORAL7000 mgExact identifier — unii candidate
81 equally ranked IID candidates
PETROLATUMPETROLATUM4T6H12BN9ULOTION / TOPICAL25 %w/wExact identifier — unii candidate
18 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3OINTMENT / RECTAL27 mgExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3SOLUTION / RESPIRATORY (INHALATION)25 %w/wExact identifier — unii candidate
81 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3FILM, EXTENDED RELEASE / TRANSDERMAL58.13 mgExact identifier — unii candidate
81 equally ranked IID candidates
EDETATE DISODIUMEDETATE DISODIUM7FLD91C86KTABLET / ORAL100 mgExact identifier — unii candidate
77 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
a66e7c0f-e3f8-4b5d-8e07-4522c86b6c38eb49a81d-35d8-415c-a6a4-111eeb7125fc2013-08-07WarningsExact identifier
spl id: a66e7c0f-e3f8-4b5d-8e07-4522c86b6c38
spl set id: eb49a81d-35d8-415c-a6a4-111eeb7125fc

Reported adverse events (FAERS/openFDA)#

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