FDA.reportPublic FDA data

Xpect Hydrocortisone

Manufacturer
Cintas Corporation | SAFETEC OF AMERICA, INC
Effective date
2025-09-26
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:14:57

Label at a glance#

ProductXpect Hydrocortisone
Active ingredientHYDROCORTISONE
Label structure10 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each gram)

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose

Anti-itch cream

INDICATIONS & USAGE SECTION

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, and scrapes
  • other uses of product should be only under the advice and supervision of a doctor 

WARNINGS SECTION

Warnings

For external use only.

OTC - DO NOT USE SECTION

Do not use

  • for the treatment of diaper rash
  • in eyes
  • for feminine itching

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worsens or lasts more than 7 days, or clears up and ocurs again within a few days
  • you begin use of any other Hydrocortisone product unless you have consulted a doctor
  • if bleeding occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. 

DOSAGE & ADMINISTRATION SECTION

Directions

  • for adults and children 2 years of age and older: apply to affected area 3 to 4 times daily
  • children under 12 years of age: for external anal itching, consult a doctor 
  • children under 2: do not use, consult a doctor
  • adults for external anal itching when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly or by patting or blotting with an appropriate cleansing pad
  • gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product

OTHER SAFETY INFORMATION

Other Information

  • clean the affected area
  • store at room temperature (do not freeze)
  • do not use any opened or torn packets

INACTIVE INGREDIENT SECTION

Inactive ingredients 

cetyl alcohol*, citric acid*, diazolidinyl urea*, edetate disodium*, emulsifying wax*, ethanol*, glycerin*, glyceryl monostearate*, methylparaben, mineral oil, paraffin*, petrolatum*, polyethylene glycol*, propylene glycol*, propylparaben, stearic acid*, trolamine*, water, white wax*
*may contain ingredient

OTC - QUESTIONS SECTION

Questions?

1-877-973-2811 M-F 8 am - 5 pm

Principal Display Panel 42961-235-02

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HYDROCORTISONE

Active Ingredient:

Hydrocortisone 1%

Anti-itch cream

For temporary relief of itching associated with minor skin irritations, inflammation, or rashes due to eczema, insect bites, poison ivy, poison oak, poison sumac, soaps, detergents, cosmetics, and other skin irritations. 

Distributed by: Cintas • Mason, OH 45040 • www.cintas.com

Xpect® First aid

NET WT PER PKT 1/32 OZ (0.9g)

10 Packets per Box 

10_CT_BOX10_CT_BOX

Principal Display Panel 42961-235-03

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HYDROCORTISONE

Hydrocortisone 1%

Anti-itch cream

For temporary relief of itching associated with minor skin irritations, inflammation, or rashes.

Xpect® First aid

Distributed by: Cintas • Mason, OH 45040 • www.cintas.com

NET WT PER PKT 1/32 OZ (0.9g)

20 Packets per Box

20_CT_BOX20_CT_BOX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
106258hydrocortisone 1 % Topical CreamPSN3
106258hydrocortisone 10 MG/ML Topical CreamSCD3
106258hydrocortisone 1 % (as hydrocortisone acetate 1.2 % ) Topical CreamSY3
106258hydrocortisone 1 % Topical CreamSY3
106258hydrocortisone 1 GM per 100 GM Topical CreamSY3

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42961-237-01Xpect Hydrocortisone0.9 g in 1 PACKETCREAM0.93
42961-237-02Xpect Hydrocortisone10 in 1 BOXCREAM103
42961-237-03Xpect Hydrocortisone20 in 1 BOXCREAM203
42961-237-04Xpect Hydrocortisone10 in 1 BAGCREAM103

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42961-23742961-237-01, 42961-237-02, 42961-237-03, 42961-237-04

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
NameUNIIKind
HYDROCORTISONEWI4X0X7BPJACTIB
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
PARAFFINI9O0E3H2ZEIACT
PETROLATUM4T6H12BN9UIACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
CETOSTEARYL ALCOHOL2DMT128M1SIACT
POLYSORBATE 60CAL22UVI4MIACT
PEG-150 DISTEARATE6F36Q0I0ACIACT
STEARETH-20L0Q8IK9E08IACT

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
Xpect HydrocortisoneHYDROCORTISONECintas Corporation45ef9be4-54c4-4d85-966b-27708313ded42025-09-26WarningsExact identifier
ndc (package): 42961-237-04
ndc (package): 42961-237-01
ndc (package): 42961-237-03
ndc (package): 42961-237-02
ndc (product): 42961-237
ndc11 (package): 42961023704
ndc11 (package): 42961023702
ndc11 (package): 42961023701
ndc11 (package): 42961023703
spl id: 1dc033fa-b07c-4fe8-b9d6-8a92c831bf4e
spl set id: 45ef9be4-54c4-4d85-966b-27708313ded4

Reported adverse events (FAERS/openFDA)#

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