FDA.reportPublic FDA data

SionBiotext Hydrocortisone

Manufacturer
Sion Biotext Medical Ltd
Effective date
2025-05-13
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:00:57

Label at a glance#

ProductSionBiotext Hydrocortisone
Active ingredientHYDROCORTISONE ACETATE
Label structure14 sections

Indications and uses

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to: Eczema insect bites poison oak poison sumac detergents cosmetics jewelry seborrheic dermatitis psoriasis for external genital feminine anal itching

Dosage and administration

adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily. children under 2 of age: consult a doctor when used for anal itching cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, painting or blotting with bathroom tissue or soft cloth before applying.

Label contents#

Full prescribing information#

Active Ingredient (In Each Gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate 1%

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-Itch)

Uses

INDICATIONS & USAGE SECTION

For the temporary relief of itching associated with minor skin irritations, inflammation, and rashes due to:

  • Eczema
  • insect bites
  • poison oak
  • poison sumac
  • detergents
  • cosmetics
  • jewelry
  • seborrheic
  • dermatitis
  • psoriasis
  • for external genital
  • feminine
  • anal itching

Warnings

WARNINGS SECTION

For external use only

Do not use

OTC - DO NOT USE SECTION

  • in the eyes
  • for diaper rash
  • for external genital or feminine itching if you have a vaginal discharge
  • more than the recommend daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any other mechanical device or applicator
  • if the seal is torn or if the tube is damaged

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens, or if symptoms persists for more than 7 days or clears up and occurs again within a few days,and do not use this or any other hydrocortisone product
  • in case of bleeding when used for anal itching

If pregnant or breastfeeding

PREGNANCY SECTION

ask a health professional before use

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed get medical help or contact a Posion Control Center right away

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults and children 2 years of age and older. Apply to affected area not more than 3 to 4 times daily.
  • children under 2 of age: consult a doctor
  • when used for anal itching cleanse the affected area with mild soap and warm water and rinse thoroughly. Gently dry, painting or blotting with bathroom tissue or soft cloth before applying.

Other Information

OTHER SAFETY INFORMATION

  • Store at 15°-30°C (59°-86°F)
  • avoid excessive heat and humidity

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Ceteareth 20, Cetostearyl Alcohol, Chlorocresol, Disodium EDTA, Mineral Oil, Propylene Glycol, Sodium metabisulfite, Water, White Petrolatum

Questions

OTC - QUESTIONS SECTION

info@sionbrands.com

Unclassified Section

SPL UNCLASSIFIED SECTION

Distributed by: SIonBrands LLC

16950 Via de Santa Fe, Rancho Santa Fe, CA, 92067

Mail Address: PO Box 450638, Laredo, TX, 78045

Email: info@sionbrands.com

Made in India

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 68786-001-28

SIONBIOTEXT

Hydrocortisone Cream 1%

Relief of Minor Skin Irritiation Itching and Rashes

For Personal and Professional Use

Net Wt: 1.0 oz (28.3g)

LabelLabel

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
68786-001-28SionBiotext Hydrocortisone28.3 g in 1 BOXCREAM28.31

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68786-001SIONBIOTEXT HYDROCORTISONE (HYDROCORTISONE ACETATE 1%) CREAM [SION BIOTEXT MEDICAL LTD]1Current NDC, 1 package rows20250515_35073eae-26fe-2bb5-e063-6294a90ab56a.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68786-00168786-001-28

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
CETEARETH-20YRC528SWUYIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
CHLOROCRESOL36W53O7109IACT
EDETATE SODIUMMP1J8420LUIACT
MINERAL OILT5L8T28FGPIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM METABISULFITE4VON5FNS3CIACT
WATER059QF0KO0RIACT
WHITE PETROLATUMB6E5W8RQJ4IACT
HYDROCORTISONE ACETATE3X7931PO74ACTIB

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
SionBiotext HydrocortisoneHYDROCORTISONE ACETATE 1%Sion Biotext Medical Ltd35073eae-26fe-2bb5-e063-6294a90ab56a2025-05-13WarningsExact identifier
ndc (package): 68786-001-28
ndc (product): 68786-001
ndc11 (package): 68786000128
spl id: 35074279-3e3d-2a74-e063-6294a90af26f
spl set id: 35073eae-26fe-2bb5-e063-6294a90ab56a

Reported adverse events (FAERS/openFDA)#

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