Hydrocortisone Cream 1%

Manufacturer: Sion Biotext Medical Ltd
Effective date: 2022-01-03
Label type: HUMAN OTC DRUG LABEL
Version: 4
Source: legacy-cache
Hydrated at: 2026-08-01 22:19:32

Label at a glance#

ProductHydrocortisone

Active ingredientHYDROCORTISONE ACETATE

Label structure13 sections

Indications and uses

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 Other uses of this product should be under the advice and supervision of a doctor.

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 ...

Storage and handling

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

Contacts and useful links#

Websitewww.sn-medical.com

www.sn-medical.com

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone Acetate, USP (1% w/w)

Purpose

OTC - PURPOSE SECTION

Antipruritic (Anti-Itch)

Uses:

INDICATIONS & USAGE 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

Other uses of this product should be 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 eyes
for diaper rash
if you have vaginal discharge
more than the recommended daily dosage

Ask a doctor before use if

OTC - ASK DOCTOR SECTION

you are pregnant or breast feeding

Stop use and ask a doctor if:

OTC - STOP USE SECTION

the condition persists or gets worse or if,
if symptoms persist for more than 7 days or clear up and occur again within a few days

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
After application, discard pad
Do not flush in toilet

Other information:

STORAGE AND HANDLING SECTION

Store at 20 ^o - 25 ^oC (68 ^o- 77 ^oF)
Avoid excessive heat and humidity

Inactive ingredients:

INACTIVE INGREDIENT SECTION

Cetostearyl Alcohol, Chlorocresol, CETETH-20, Edetate Disodium, Liquid Paraffin, Propylene Glycol, Purified Water, Sodium Betabisulphite, White Soft Paraffin

SPL UNCLASSIFIED SECTION

Sion Biotext Medical Ltd. Hagoshrim, 1222500, ISRAEL. Email: sales@sn-medical.com Tel: +972-4-6956201

www.sn-medical.com

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC # 68786-224-02

Sion Biotext Medical Ltd.

For Professional and Hospital Use

Hydrocortisone Cream 1%

Relief of Minor Skin Irritation, Itching and Rashes

Ref: 54C813-9401-000

Net Wt 0.9gram

144 Packets

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROCORTISONE ACETATE	ACTIVE INGREDIENT	3X7931PO74	1
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	1
CETETH-20	INACTIVE INGREDIENT	I835H2IHHX	1
CETOSTEARYL ALCOHOL	INACTIVE INGREDIENT	2DMT128M1S	1
CHLOROCRESOL	INACTIVE INGREDIENT	36W53O7109	1
EDETATE DISODIUM	INACTIVE INGREDIENT	7FLD91C86K	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	1
MINERAL OIL	INACTIVE INGREDIENT	T5L8T28FGP	1
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	1
SODIUM METABISULFITE	INACTIVE INGREDIENT	4VON5FNS3C	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

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

Hydrocortisone
Hydrocortisone Acetate
PROPYLENE GLYCOL
WATER
CETETH-20
CETOSTEARYL ALCOHOL
CHLOROCRESOL
EDETATE DISODIUM
MINERAL OIL
SODIUM METABISULFITE
LIGHT MINERAL OIL

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
68786-224	68786-224-06, 68786-224-05, 68786-224-02, 68786-224-03, 68786-224-04

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
Name	UNII	Kind
PROPYLENE GLYCOL	6DC9Q167V3	IACT
WATER	059QF0KO0R	IACT
CETETH-20	I835H2IHHX	IACT
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
CHLOROCRESOL	36W53O7109	IACT
EDETATE DISODIUM	7FLD91C86K	IACT
MINERAL OIL	T5L8T28FGP	IACT
SODIUM METABISULFITE	4VON5FNS3C	IACT
LIGHT MINERAL OIL	N6K5787QVP	IACT
HYDROCORTISONE ACETATE	3X7931PO74	ACTIB

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 · 265 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPRAY / SUBLINGUAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SYSTEM / TRANSDERMAL	6.09 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TABLET, DELAYED RELEASE / ORAL		36 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRACARDIAC		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION, SOLUTION / SUBCUTANEOUS	1.4 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	TABLET, EXTENDED RELEASE / ORAL		800 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	GEL / OPHTHALMIC	0.44 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SPONGE / TOPICAL	40 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / TOPICAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / AURICULAR (OTIC)	ADJ PH		Exact identifier — unii candidate 81 equally ranked IID candidates
CETETH-20	CETETH-20	I835H2IHHX	TAMPON / VAGINAL	NA		Exact identifier — unii candidate 4 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	TABLET, COATED / ORAL	1.5 mg		Exact identifier — unii candidate 30 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, FILM COATED / ORAL	2.49 mg		Exact identifier — unii candidate 19 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SPRAY / TOPICAL		1379 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CAPSULE, COATED / ORAL	25 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / INTRAMUSCULAR		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	OINTMENT / TOPICAL	1.2 %w/w		Exact identifier — unii candidate 9 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	SOAP / TOPICAL	0.82 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	SYSTEM / TRANSDERMAL		170 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	INJECTION / INTRAMUSCULAR		7459 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	CAPSULE / ORAL		120 mg	Exact identifier — unii candidate 30 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / ORAL		432 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION, SOLUTION / SUBMUCOSAL	5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, DELAYED RELEASE / ORAL		100 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	FILM, SOLUBLE / BUCCAL		5 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, CHEWABLE / ORAL		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / ORAL		4 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / INTRAVENOUS	10 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	PASTE / DENTAL		687 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CLOTH / TOPICAL	0.03 mg/mg		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, EMULSION / INTRAVENOUS		59 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SUSPENSION/ DROPS / OPHTHALMIC		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	EMULSION / OPHTHALMIC	1.5 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	PASTE / DENTAL	95 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT, AUGMENTED / TOPICAL		714 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SUSPENSION / INTRA-ARTICULAR		1 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	DROPS / OPHTHALMIC	0.05 %w/v		Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / OPHTHALMIC		396 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	OINTMENT / RECTAL		27 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
CETOSTEARYL ALCOHOL	CETOSTEARYL ALCOHOL	2DMT128M1S	AEROSOL, FOAM / TOPICAL		21 mg	Exact identifier — unii candidate 9 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SOLUTION / RECTAL		97 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / RESPIRATORY (INHALATION)	10 %w/w		Exact identifier — unii candidate 81 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	LOTION / TOPICAL		48000 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRAMUSCULAR	27.5 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION / SUBCUTANEOUS		6 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	INJECTION, SOLUTION / SUBCUTANEOUS		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION, CONCENTRATE / INTRAVENOUS	50.33 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	INJECTION / INTRAPERITONEAL	0.33 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	LIQUID / ORAL		29008 mg	Exact identifier — unii candidate 81 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	LOTION / TOPICAL	0.2 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
MINERAL OIL	MINERAL OIL	T5L8T28FGP	GEL / TOPICAL	2.5 %w/w		Exact identifier — unii candidate 30 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	AEROSOL, FOAM / TOPICAL		240 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	SYSTEM / TOPICAL		126 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	SUSPENSION / TOPICAL	0.32 %w/v		Exact identifier — unii candidate 43 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	TABLET, FILM COATED / ORAL	4 mg		Exact identifier — unii candidate 77 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	SOLUTION/ DROPS / OPHTHALMIC	0.75 %w/v		Exact identifier — unii candidate 81 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	TAMPON / VAGINAL	62.1 mg		Exact identifier — unii candidate 81 equally ranked IID candidates
EDETATE DISODIUM	EDETATE DISODIUM	7FLD91C86K	CREAM, AUGMENTED / TOPICAL		2 mg	Exact identifier — unii candidate 77 equally ranked IID candidates
SODIUM METABISULFITE	SODIUM METABISULFITE	4VON5FNS3C	TABLET / SUBLINGUAL	2 mg		Exact identifier — unii candidate 43 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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
efe17cf3-42f1-8b4a-e053-2a95a90acee7			42afcd95-b81d-4a62-b006-10be46ea58fd	2022-12-15	Warnings	Exact identifier spl set id: 42afcd95-b81d-4a62-b006-10be46ea58fd

Reported adverse events (FAERS/openFDA)#

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