091 Curad Hydrocortisone 1% Cream Anti-itch

Manufacturer: Medline Industries, LP
Effective date: 2025-10-09
Label type: HUMAN OTC DRUG LABEL
Version: 14
Source: daily-update
Hydrated at: 2026-07-18 05:11:04

Label at a glance#

ProductAnti-itch

Active ingredientHYDROCORTISONE

Label structure10 sections

Indications and uses

for the temporary relief of itching associated with minor skin irritations, inflammation and rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis for external genital, feminine and anal itching other uses of this product should be only under the advice and supervision of a doctor

Dosage and administration

For 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 of age: do not use, consult a doctor. For external anal itching, Adults: When practical, cleanse 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 application of this product. Children under 12 yea...

Storage and handling

Store at controlled room temperature 68°-77° F (20°-25° C). Use only if package is intact.

Contacts and useful links#

PhoneLabel contact1-800-633-5463

Websitewww.curad.com

www.curad.com

Label contents#

Full prescribing information#

Active ingredient (in each gram)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone 1%, USP

Purpose

OTC - PURPOSE SECTION

Antipuritic (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 ivy, poison oak, poison sumac, soaps, detergents, cosmetics, jewelry, seborrheic dermatitis, psoriasis
for external genital, feminine and anal itching
other uses of this product should be only under the advice and supervision of a doctor

Warnings

WARNINGS SECTION

for external use only
avoid contact with eyes

Do not use and consult a doctor

OTC - DO NOT USE SECTION

for the treatment of diaper rash
if you have a vaginal discharge
If condition worsens, or if symptoms persist for more than 7 days or clear up and occur again within a few days, stop use of this product and do not begin use of any other hydrocortisone product unless you have consulted a doctor.

Do not exceed the recommended daily dosage unless directed by the doctor. In case of bleeding, consult a physician promptly. Do not put this product into the rectum by using fingers or any mechanical device or applicator.

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 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 of age: do not use, consult a doctor.

For external anal itching,

Adults: When practical, cleanse 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 application of this product.
Children under 12 years of age: consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Store at controlled room temperature 68°-77° F (20°-25° C).
Use only if package is intact.

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetostearyl alcohol, glyceryl monostearate SE, kathon CG, propylene glycol, purified water, stearic acid, trolamine, white petrolatum.

Manufacturing Information

SPL UNCLASSIFIED SECTION

Manufactured for:

Medline Industries, LP

Three Lakes Drive, Northfield, IL 60093 USA

Made in India

www.curad.com

1-800-633-5463

REF: CUR015431

Recent Major Changes

RECENT MAJOR CHANGES SECTION

Updated indications and usage section

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Box

Product Linked Resources#

Resource, Code type, Value table
Resource	Code type	Value	Equivalent identifiers	Source image
Barcode	EAN-13	0884389111522	GTIN-13: 0884389111522 EAN-13: 0884389111522 GTIN-12: 884389111522 UPC-A: 884389111522 GTIN storage (14 digits): 00884389111522	53329-091-01_V3 RL24GZP.jpg

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
53329-091-01	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-01	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-08-08	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-01	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-01	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-90	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-91	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch
53329-091-96	2023-07-28	C162847	48780-1	0191ceaa-6e10-198a-e063-dbdaa90aec3e	091 Curad Hydrocortisone 1% Cream Anti-itch

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
53329-091-01	GM - Gram	53329-091	9ab0f641-eef6-4977-a15b-abc165bf39b7	1	2018-08-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
HYDROCORTISONE	ACTIVE INGREDIENT	WI4X0X7BPJ	6
HYDROCORTISONE	ACTIVE MOIETY	WI4X0X7BPJ	6
CITRIC ACID MONOHYDRATE	INACTIVE INGREDIENT	2968PHW8QP	6
GLYCERIN	INACTIVE INGREDIENT	PDC6A3C0OX	6
GLYCERYL STEARATE CITRATE	INACTIVE INGREDIENT	WH8T92A065	6
METHYLPARABEN	INACTIVE INGREDIENT	A2I8C7HI9T	6
PETROLATUM	INACTIVE INGREDIENT	4T6H12BN9U	6
POLYSORBATE 80	INACTIVE INGREDIENT	6OZP39ZG8H	6
PROPYLENE GLYCOL	INACTIVE INGREDIENT	6DC9Q167V3	6
PROPYLPARABEN	INACTIVE INGREDIENT	Z8IX2SC1OH	6
SODIUM CITRATE	INACTIVE INGREDIENT	1Q73Q2JULR	6
TITANIUM DIOXIDE	INACTIVE INGREDIENT	15FIX9V2JP	6
WATER	INACTIVE INGREDIENT	059QF0KO0R	6

Products#

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

DailyMed product names page 1 of 1 · 10 matching rows.

Anti-itch
hydrocortisone
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE
STEARIC ACID
TROLAMINE
WHITE PETROLATUM
WATER
CETOSTEARYL ALCOHOL
PROPYLENE GLYCOL
GLYCERYL MONOSTEARATE

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
53329-091	53329-091-01, 53329-091-90, 53329-091-91, 53329-091-96

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
Name	UNII	Kind
METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE	15O9QS218W	IACT
STEARIC ACID	4ELV7Z65AP	IACT
TROLAMINE	9O3K93S3TK	IACT
WHITE PETROLATUM	B6E5W8RQJ4	IACT
WATER	059QF0KO0R	IACT
HYDROCORTISONE	WI4X0X7BPJ	ACTIB
CETOSTEARYL ALCOHOL	2DMT128M1S	IACT
PROPYLENE GLYCOL	6DC9Q167V3	IACT
GLYCERYL MONOSTEARATE	230OU9XXE4	IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
Version	Effective date	Source	Hydrated
13	2025-01-10	full-release	2026-06-01 00:52:12

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 1 · 40 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Maximum daily exposure	Match
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL	6 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL	76000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL	3000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL	80 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL	76000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL	20 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL	1720 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL	6 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL	3000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL	80 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL	80 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL	20 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL	4 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL	1720 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL	6 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL	6 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL	76000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL	3000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL	3000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
METHYLPARABEN	METHYLPARABEN	A2I8C7HI9T	CREAM / TOPICAL	3000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL	80 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL	20 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL	4 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL	4 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PETROLATUM	PETROLATUM	4T6H12BN9U	CREAM / TOPICAL	4213 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL	76000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL	4 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
CITRIC ACID MONOHYDRATE	CITRIC ACID MONOHYDRATE	2968PHW8QP	CREAM / TOPICAL	4 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL	1720 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL	1720 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLPARABEN	PROPYLPARABEN	Z8IX2SC1OH	CREAM / TOPICAL	6 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
PROPYLENE GLYCOL	PROPYLENE GLYCOL	6DC9Q167V3	CREAM / TOPICAL	76000 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL	20 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
TITANIUM DIOXIDE	TITANIUM DIOXIDE	15FIX9V2JP	CREAM / TOPICAL	80 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
POLYSORBATE 80	POLYSORBATE 80	6OZP39ZG8H	CREAM / TOPICAL	20 mg	Exact identifier — unii+route+dosage form 5 equally ranked IID candidates
GLYCERIN	GLYCERIN	PDC6A3C0OX	CREAM / TOPICAL	1720 mg	Exact identifier — unii+route+dosage form 5 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
Anti-itch	HYDROCORTISONE	Medline Industries, LP	b0947381-c0db-4253-ab40-3d45603ae65d	2025-10-09	Warnings	Exact identifier ndc (package): 53329-091-90 ndc (package): 53329-091-96 ndc (package): 53329-091-91 ndc (package): 53329-091-01 ndc (product): 53329-091 ndc11 (package): 53329009101 ndc11 (package): 53329009196 ndc11 (package): 53329009191 ndc11 (package): 53329009190 spl id: 40c054e1-8661-4940-e063-6294a90a0200 spl set id: b0947381-c0db-4253-ab40-3d45603ae65d

Reported adverse events (FAERS/openFDA)#

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