FDA.reportPublic FDA data

Anti-itch cream

Manufacturer
Shares inc
Effective date
2022-08-19
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:50:30

Label at a glance#

ProductAnti-itch cream
Active ingredientHYDROCORTISONE ACETATE
Label structure13 sections

Indications and uses

temporarily relieves itching associated with minor skin irritations and rashes due to: eczema insect bites poison ivy, oak, or sumac soaps, detergents, or cosmetics jewelry

Dosage and administration

Adults and children 2 years and over - apply to affected area not more than 3 to 4 times daily children under 2 years - do not use

Label contents#

Full prescribing information#

Active ingredients (in each packet)

OTC - ACTIVE INGREDIENT SECTION

Hydrocortisone acetate 1%

Purpose

OTC - PURPOSE SECTION

anti-itch cream

Uses

INDICATIONS & USAGE SECTION

temporarily relieves itching associated with minor skin irritations and rashes due to:

  • eczema
  • insect bites
  • poison ivy, oak, or sumac
  • soaps, detergents, or cosmetics
  • jewelry

Warnings

WARNINGS SECTION

for external use only

Do not use

OTC - DO NOT USE SECTION

  • with any other hydrocortisone product unless you have consulted a doctor
  • for the treatment of diaper rash, consult a doctor

When using this product

OTC - WHEN USING SECTION

avoid contact with eyes

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • condition worsens
  • symptoms persist for more than 7 days
  • symptoms 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 2 years and over - apply to affected area not more than 3 to 4 times daily

children under 2 years - do not use

Other information

OTHER SAFETY INFORMATION

  • do not use if package is torn, cut or opened
  • store at room tempreature (do not freeze)
  • see packet for Lot Number and expiration date

Inactive ingredients

INACTIVE INGREDIENT SECTION

cetyl alcohol, citric acid, diazolidinyl urea, edetate disodium, glycerin, glyceryl monostearate, methylparaben, mineral oil, polyethylene glycol, propylene glycol, propylparaben, purified water, stearic acid, trolamine

Questions

OTC - QUESTIONS SECTION

1-877-973-2811 Monday - Friday 8:00 AM to 5:00 PM

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hydrocortisone

1% hydrocortisone anti-itch cream

Net wt per pkt 1/32 oz (0.9 g)

20 pkts per box

Front PanelFront Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1043690hydrocortisone acetate 1 % Topical CreamPSN1
1043690hydrocortisone acetate 10 MG/ML Topical CreamSCD1
1043690hydrocortisone acetate 1 % Topical CreamSY1

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
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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
82940-220-012023-07-28C16284748780-10191ceaa-6a38-198a-e063-dbdaa90aec3eHydrocortisone Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82940-220-01Anti-itch cream0.9 g in 1 PACKETCREAM0.91
82940-220-01Anti-itch cream20 in 1 BOXCREAM201

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
82940-220ANTI-ITCH CREAM (HYDROCORTISONE CREAM) CREAM [SHARES INC]1Legacy NDC, 2 package rows20220823_e6a0968f-5341-f7e1-e053-2995a90ae952.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82940-22082940-220-01
42961-220

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
HYDROCORTISONE ACETATE3X7931PO74ACTIB
PROPYLPARABENZ8IX2SC1OHIACT
EDETATE DISODIUM7FLD91C86KIACT
WATER059QF0KO0RIACT
TROLAMINE9O3K93S3TKIACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
STEARIC ACID4ELV7Z65APIACT

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
e6a0968f-5342-f7e1-e053-2995a90ae952e6a0968f-5341-f7e1-e053-2995a90ae9522022-08-19WarningsExact identifier
spl id: e6a0968f-5342-f7e1-e053-2995a90ae952
spl set id: e6a0968f-5341-f7e1-e053-2995a90ae952

Reported adverse events (FAERS/openFDA)#

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