Hydrocortisone

Manufacturer: Kareway Product, Inc.
Effective date: 2023-01-27
Label type: HUMAN OTC DRUG LABEL
Version: 5
Source: full-release
Hydrated at: 2026-05-31 23:53:33

Label at a glance#

ProductHydrocortisone

Active ingredientHYDROCORTISONE

Label structure8 sections

Indications and uses

temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to: eczema insect bites poison ivy, oak, sumac soaps detergents cosmetics jewelry seborrheic dermatitis psoriasis temporarily relieves external anal and genital itching other uses of this product should only be 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: Ask a doctor for external anal and genital itching, adults: when practical, clean the affected area with mild soap and water and rinse thoroughly gently dry by patting or blotting with toilet tissue or a soft cloth before applying ap...

Storage and handling

store at 20 to 25 o C (68 to 77 o F) see end of carton or tube crimp for lot number and expiration date

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%

Purpose

OTC - PURPOSE SECTION

Anti-itch

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itching associated with minor sin irritation, inflammation and rashes due to:

eczema
insect bites
poison ivy, oak, sumac
soaps
detergents
cosmetics
jewelry
seborrheic dermatitis
psoriasis
temporarily relieves external anal and genital itching
other uses of this product should only 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 genital area if you have a vaginal discharge. Consult a doctor.
for the treatment of diaper rash. Ask 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 us of any other hydrocortisone product unless you have asked a doctor
rectal bleeding occurs

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

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: Ask a doctor
for external anal and genital itching, adults:
when practical, clean the affected area with mild soap and 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

store at 20 to 25 ^oC (68 to 77 ^oF)
see end of carton or tube crimp for lot number and expiration date

INACTIVE INGREDIENT SECTION

butylated hydroxytoluene, carbomer 940, cetyl alcohol, ethylparaben, glycerin, glyceryl stearate, propylene glycol, sodium lauryl sulfate, stearic acid, trolamine, water

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone

carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUI	RxNorm string	TTY	SPL version
106258	hydrocortisone 1 % Topical Cream	PSN	5
106258	hydrocortisone 10 MG/ML Topical Cream	SCD	5
106258	hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical Cream	SY	5
106258	hydrocortisone 1 % Topical Cream	SY	5
106258	hydrocortisone 1 GM per 100 GM Topical Cream	SY	5

DailyMed Pharmacologic Classes#

Class, Version, Type table
Class	Version	Type	Effective
HYDROCORTISONE Pharmacologic Class Indexing	2	Indexing - Pharmacologic Class	20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product concept	Relation	Version	Effective
15bd4439-874a-4934-9954-248e5455d460	Product name	1	20260310
9962b773-9f2e-22cc-0032-535e48ac417b	Product name	3	20250724
56bb0587-1bf2-48b2-9d93-fc9f59d1eeb2	Product name	1	20250325
4d56e8eb-d741-d4a5-de3f-2bab1af75a60	Product name	7	20220608
626d7260-31b5-4412-84fd-579746adb6b3	Product name	1	20210513
8a011600-5e61-4c59-ab7b-54ab658a3b71	Product name	2	20181127
a919621a-248d-3c7a-1084-9f9ce286fdfd	Product name	2	20181009
e7d5a174-836b-a0af-b014-cb0826c69ddc	Product name	2	20181004
fcce390d-6460-4701-87cf-940d8800a1c3	Product name	2	20180212
bf065fa6-1e3b-e4c3-0bde-2dc842ceeea1	Product name	2	20150218
02657a3f-1489-66ea-f740-5ab9524e57d7	Product name	1	20140508
26f3d783-2cc1-4327-e77d-71804cf675a2	Product name	1	20140508
36fdc54c-bbeb-981e-8a53-4d768e283892	Product name	1	20140508
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8	Product name	1	20140508
61e59a42-186b-9f4b-aec3-fb49a6debc31	Product name	1	20140508
705740e1-dee5-2610-c5a3-4c59cd9d62af	Product name	1	20140508
7bdc4804-3832-c0df-e519-72b6d47c9792	Product name	1	20140508
a7051cba-790b-a699-81f8-dbbbdbd9b5ac	Product name	1	20140508
abaf203f-619e-f265-559f-8c81af5cb1c2	Product name	1	20140508
acc4d8bb-0e29-e9f8-65f8-31e94184a9c0	Product name	1	20140508
b045ad64-0f28-9a02-2f9b-b34d94fb2278	Product name	1	20140508
bfd28ffb-d550-3fe9-f65b-10bcb7f971fd	Product name	1	20140508
da108d9e-edc8-17a3-8c28-3251c6a8accc	Product name	1	20140508
fe21f3fd-a378-0654-1972-db3c3b64470e	Product name	1	20140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
67510-0632-1	2025-01-30	C162847	48780-1	ab0e2407-2c1f-f274-e053-dbdaa90a6471	Soundbody Hydrocortisone
67510-0632-1	2020-10-07	C162847	48780-1	ab0e2407-2c1f-f274-e053-dbdaa90a6471	Soundbody Hydrocortisone
67510-0632-1	2020-09-27	C162847	48780-1	ab0e2407-2c1f-f274-e053-dbdaa90a6471	Soundbody Hydrocortisone
67510-0632-1	2020-09-25	C162847	48780-1	ab0e2407-2c1f-f274-e053-dbdaa90a6471	Soundbody Hydrocortisone
67510-0632-1	2020-07-22	C162847	48780-1	ab0e2407-2c1f-f274-e053-dbdaa90a6471	Soundbody Hydrocortisone

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDC	Product	Description	Form	Quantity	Strength	SPL version
67510-0632-1	Hydrocortisone	1 in 1 BOX	CREAM	1		5
67510-0632-1	Hydrocortisone	28.3 g in 1 TUBE	CREAM	28.3		5

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDC	Dashboard title	SPL version	Validation	Dashboard ZIP
67510-0632	HYDROCORTISONE CREAM [KAREWAY PRODUCT, INC.]	5	Legacy NDC, 2 package rows	20230129_ca115f18-6bee-4df2-86e4-3e90dc33003a.zip

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
Hydrocortisone	ACTIVE INGREDIENT	WI4X0X7BPJ	1
Hydrocortisone	ACTIVE MOIETY	WI4X0X7BPJ	1
Cetyl alcohol	INACTIVE INGREDIENT	936JST6JCN	1
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	1
LIGHT MINERAL OIL	INACTIVE INGREDIENT	N6K5787QVP	1
MALTODEXTRIN	INACTIVE INGREDIENT	7CVR7L4A2D	1
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	1
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	1
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	1
SODIUM CETYL SULFATE	INACTIVE INGREDIENT	3V3Y3O7BIQ	1
SODIUM LAURYL SULFATE	INACTIVE INGREDIENT	368GB5141J	1
WATER	INACTIVE INGREDIENT	059QF0KO0R	1

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

Hydrocortisone
TROLAMINE
BUTYLATED HYDROXYTOLUENE
ETHYLPARABEN
CETYL ALCOHOL
GLYCERIN
CARBOMER 940
GLYCERYL 1-STEARATE
STEARIC ACID
PROPYLENE GLYCOL
SODIUM LAURYL SULFATE
WATER

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
67510-0632	67510-0632-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
Name	UNII	Kind
TROLAMINE	9O3K93S3TK	IACT
BUTYLATED HYDROXYTOLUENE	1P9D0Z171K	IACT
ETHYLPARABEN	14255EXE39	IACT
CETYL ALCOHOL	936JST6JCN	IACT
GLYCERIN	PDC6A3C0OX	IACT
CARBOMER 940	4Q93RCW27E	IACT
GLYCERYL 1-STEARATE	258491E1RZ	IACT
STEARIC ACID	4ELV7Z65AP	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
SODIUM LAURYL SULFATE	368GB5141J	IACT
WATER	059QF0KO0R	IACT
HYDROCORTISONE	WI4X0X7BPJ	ACTIB

Source Document#

Source XML · Source PDF

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 6 · 336 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / VAGINAL	3 mg		Exact identifier — unii candidate 42 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	OINTMENT, AUGMENTED / TOPICAL	81.94 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LIQUID / ORAL		2400 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRA-ARTICULAR	0.03 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, EXTENDED RELEASE / ORAL		320 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION / INTRAMUSCULAR		6 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	LOTION / TOPICAL		3990 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION/ DROPS / AURICULAR (OTIC)		25 mg	Exact identifier — unii candidate 75 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
Cetyl alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, FILM COATED, EXTENDED RELEASE / ORAL	59 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SYRUP / ORAL		16734 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / VAGINAL		60 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	LOTION / TOPICAL	25 %w/w		Exact identifier — unii candidate 18 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	TABLET, EXTENDED RELEASE / ORAL		1 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / VAGINAL		22 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / RECTAL	0.13 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / VAGINAL		3 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Cetyl alcohol	CETYL ALCOHOL	936JST6JCN	AEROSOL / TOPICAL	1.16 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SOLUTION / TOPICAL		1971 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, COATED / ORAL	14.21 mg		Exact identifier — unii candidate 75 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	SUSPENSION/ DROPS / ORAL		750 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CREAM / VAGINAL		12 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION, CONCENTRATE / ORAL	0.2 mg/1ml		Exact identifier — unii candidate 68 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SOLUTION / ORAL		13 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	TABLET, CHEWABLE / ORAL		6 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, ORALLY DISINTEGRATING / ORAL		12 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAVENOUS	15 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	OINTMENT / TOPICAL		14 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
Cetyl alcohol	CETYL ALCOHOL	936JST6JCN	SUSPENSION / TOPICAL	2.01 %w/w		Exact identifier — unii candidate 20 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	TABLET, EXTENDED RELEASE / ORAL		7 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SUSPENSION, EXTENDED RELEASE / ORAL		4 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	TABLET, EFFERVESCENT / ORAL		14404 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, SUSPENSION / SUBCUTANEOUS	0.16 %w/v		Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SUSPENSION / ORAL		388 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	INJECTION, SOLUTION / INTRAVENOUS		5 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CAPSULE, EXTENDED RELEASE / ORAL		265 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION/ DROPS / OPHTHALMIC	0.01 %w/v		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	TABLET, EXTENDED RELEASE / ORAL	0.17 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CAPSULE, EXTENDED RELEASE / ORAL	0.22 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR	3.6 mg		Exact identifier — unii candidate 79 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CONCENTRATE / ORAL		1800 mg	Exact identifier — unii candidate 75 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CAPSULE, EXTENDED RELEASE / ORAL		2 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SUSPENSION / ORAL		75 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	DROPS / AURICULAR (OTIC)	0.01 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
LIGHT MINERAL OIL	LIGHT MINERAL OIL	N6K5787QVP	CAPSULE / ORAL		6 mg	Exact identifier — unii candidate 19 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	SOLUTION / NASAL	140 mg		Exact identifier — unii candidate 68 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	INSERT / VAGINAL		15 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	GEL / TOPICAL		24 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	CAPSULE / ORAL		600 mg	Exact identifier — unii candidate 42 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	INJECTION / PARENTERAL		18 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
MALTODEXTRIN	MALTODEXTRIN	7CVR7L4A2D	SOLUTION / ORAL		1451 mg	Exact identifier — unii candidate 15 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	POWDER, FOR SOLUTION / ORAL		126 mg	Exact identifier — unii candidate 79 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	SOLUTION / OPHTHALMIC	0.05 %w/w		Exact identifier — unii candidate 79 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	POWDER, FOR SUSPENSION / ORAL		8 mg	Exact identifier — unii candidate 68 equally ranked IID candidates
Cetyl alcohol	CETYL ALCOHOL	936JST6JCN	TABLET, COATED / ORAL	0.25 mg		Exact identifier — unii candidate 20 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	TABLET, EXTENDED RELEASE / ORAL	0.18 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CAPSULE, EXTENDED RELEASE / ORAL	0.07 mg		Exact identifier — unii candidate 18 equally ranked IID candidates
SODIUM LAURYL SULFATE	SODIUM LAURYL SULFATE	368GB5141J	POWDER / RESPIRATORY (INHALATION)	NA		Exact identifier — unii candidate 42 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	INJECTION / INTRADERMAL	1.6 %w/v		Exact identifier — unii candidate 75 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM, AUGMENTED / TOPICAL	26 %w/w		Exact identifier — unii candidate 18 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
f344a0a6-509a-27b3-e053-2995a90a6c43			ca115f18-6bee-4df2-86e4-3e90dc33003a	2023-01-27	Warnings	Exact identifier spl id: f344a0a6-509a-27b3-e053-2995a90a6c43 spl set id: ca115f18-6bee-4df2-86e4-3e90dc33003a

Reported adverse events (FAERS/openFDA)#

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