Assured

Manufacturer
Zhejiang Jingwei Pharmaceutic Al Co., Ltd.
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-05-31 23:57:35

Label at a glance#

ProductAssured
Active ingredientHYDROCORTISONE
Label structure10 sections

Storage and handling

Other information •store at room temperature 68° - 77° F (20° - 25° C)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose

Anti-itch

INDICATIONS & USAGE SECTION

Uses

•temporarily relieves itching ssociated with minor skin

irritation, inflammation and rashesdue to:

•eczema      •psoriasis      •poison ivy, oak, sumac

•insect bites   •detergents   •jewelry

•cosmetics   •soaps   •seborrheic dermatitis

•temporarily relieves external anal and genital itching

•other uses of this product should be under advice and

supervision of a doctor

WARNINGS SECTION

. Warnings. For external use only

•in the genital area if you have a vaginal Do not use

discharge. Consult a doctor  •for the treatment of diaper

rash. Consult a doctor.

When using this product

•avoid contact with eyes.

•do not use more than directed unless told to do so by a doctor.

•do not put directly into rectum by using fingers or

any mechanical device or applicator.

Stop use and ask a doctor if

•condition worsens, symptoms persist for more than 7 days

or clear up and occur again within a few days, and do not

begin use of any other hydrocortisone product unless you

have asked a doctor.   •rectal bleeding occurs.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

. If swallowed, get medical Keep out of reach of children

help or contract a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Directions

• : for relieving 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 of age: ask a doctor

• s: for external anal and genital itching, adult

•when practical, clean the affected area with mild soap

and warm water and rinse thoroughly

•gently dry by patting or blotting with toilet tissue or 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

STORAGE AND HANDLING SECTION

Other information

•store at room temperature 68° - 77° F (20° - 25° C)

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, cetyl alcohol, Inactive ingredients

dimethicone, EDTA, ethylparaben, glycerin, glyceryl monostearate,

isohexadecane, maltodextrin, methyl gluceth-20, methyparaben, petrolatum,

phenoxyethanol, polysorbate 80, propylene glycol, sodium citrate, stearic

acid, tocopherol, water, zingiber officinale (ginger) root extract

OTC - QUESTIONS SECTION

1-800-639-3803  Weekdays 9 AM to 4 PM EST Questions?

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN6
106258hydrocortisone 10 MG/ML Topical CreamSCD6
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY6
106258hydrocortisone 1 % Topical CreamSY6
106258hydrocortisone 1 GM per 100 GM Topical CreamSY6

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
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
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
55621-018-28Assured28 g in 1 TUBECREAM286
55621-018-28Assured1 in 1 CARTONCREAM16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55621-018ASSURED (HYDROCORTISONE) CREAM [ZHEJIANG JINGWEI PHARMACEUTIC AL CO., LTD.]6Current NDC, Legacy NDC, 2 package rows20231025_bc97f364-9443-47b8-9c2d-b5dcc00cc9b7.zip

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55621-01855621-018-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 21 matching rows.

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
AssuredHYDROCORTISONEZhejiang Jingwei Pharmaceutic Al Co., Ltd.bc97f364-9443-47b8-9c2d-b5dcc00cc9b72023-10-25WarningsExact identifier
ndc (package): 55621-018-28
ndc (product): 55621-018
ndc11 (package): 55621001828
spl id: 08846c1b-91dd-aadf-e063-6294a90accfa
spl set id: bc97f364-9443-47b8-9c2d-b5dcc00cc9b7

Reported adverse events (FAERS/openFDA)#

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