FDA.reportPublic FDA data

Hydrocortisone Cream 1%

Manufacturer
Sion Biotext Medical Ltd
Effective date
2022-01-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:19:32

Label at a glance#

ProductHydrocortisone
Active ingredientHYDROCORTISONE
Label structure9 sections

Indications and uses

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

Dosage and administration

adults and children 2 years of age and older: Apply to affected area not more than 3 or 4 times daily. children under 2 years of age: Consult a doctor When used for anal itching, cleanse the affected area with mild soap and warm waterand risne thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying children under 12: ​Consult a doctor before using for anal itching

Storage and handling

store at 15 o - 30 o C (59 o - 86 o F) avoid excessive heat and humidity

Label contents#

Full prescribing information#

Active Ingredient (In Each Gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%   

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-Itch)

Uses:

INDICATIONS & USAGE SECTION

For temporary relief of itching associated with

  • minor skin irritations
  • inflammation

and rashes due to

  • eczema
  • insect bites
  • poison ivy
  • poison oak
  • poison sumar
  • detergents
  • cosmetics
  • jewelry
  • seborrheic dermatitis
  • psoriasis

and for external genital, feminine and anal itching

Warnings:

WARNINGS SECTION

FOR EXTERNAL USE ONLY

​If pregnant or breastfeeding, ask a health professional before use.

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 recommended daily dosage unless directed by a doctor
  • this product in the rectum by using fingers or any other mechanical device or applicator

Stop use and ask a doctor if

OTC - ASK DOCTOR SECTION

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

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 2 years of age and older:

  • Apply to affected area not more than 3 or 4 times daily.

children under 2 years of age:

  • Consult a doctor
  • When used for anal itching, cleanse the affected area with mild soap and warm waterand risne thoroughly. Gently dry, patting or blotting with bathroom tissue or soft cloth before applying

children under 12:

  • ​Consult a doctor before using for anal itching

Other information:

STORAGE AND HANDLING SECTION

  • store at 15 o - 30 oC (59 o - 86 oF)
  • avoid excessive heat and humidity

Inactive Ingredients:

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol,Glyceryl Monostearate SE, Methylchloroisothiazolinone, Propylene Glycol, Purified Water, Stearic Acid, Triethanolamine, White Soft Paraffin

Distributed by

SPL UNCLASSIFIED SECTION

​SIONBRANDS, INC. ​754 Roble Rd, Suite 180, Allentown, PA, 18109, USA.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC # 68786-223-01

SiON BiOTEXT

For Personal and Professional Use

Hydrocortisone Cream 1%

Relief of Minor Skin Irritation, Itching and Rashes

Net Wt: 1.0 oz (28.3 g)

LabelLabel

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
68786-22368786-223-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
METHYLCHLOROISOTHIAZOLINONEDEL7T5QRPNIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
STEARIC ACID4ELV7Z65APIACT
TROLAMINE9O3K93S3TKIACT
PETROLATUM4T6H12BN9UIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
efe18723-ca63-3d08-e053-2995a90abe942c07e434-cea9-4f8b-a0cf-6fc53cf3f2e72022-12-15WarningsExact identifier
spl set id: 2c07e434-cea9-4f8b-a0cf-6fc53cf3f2e7

Reported adverse events (FAERS/openFDA)#

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