FDA.reportPublic FDA data

PREPARATION H SOOTHING RELIEF ANTI-ITCH

Manufacturer
Haleon US Holdings LLC
Effective date
2025-07-07
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:06:38

Label at a glance#

ProductPREPARATION H SOOTHING RELIEF ANTI-ITCH
Active ingredientHYDROCORTISONE
Label structure10 sections

Storage and handling

Other information store at 20–25°C (68–77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Hydrocortisone 1%

OTC - PURPOSE SECTION

Purpose

Anti-itch

INDICATIONS & USAGE SECTION

Uses

  • temporary relief of external anal itching
  • temporary relief of itching associated with minor skin irritations and rashes
  • other uses of this 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 usefor the treatment of diaper rash. Consult a doctor.

When using this product

OTC - WHEN USING SECTION

  • avoid contact with the eyes
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens
  • symptoms persist for more than 7 days or clear up and occur again within a few days. Do not begin use of any other hydrocortisone product unless you have consulted a doctor.

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

  • adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing wipe. Gently dry by patting or blotting with a tissue or soft cloth before application of this product.
  • when first opening the tube, puncture foil seal with top end of cap
  • adults and children 12 years of age and older: apply to the affected area not more than 3 to 4 times daily
  • children under 12 years of age: do not use, consult a doctor

STORAGE AND HANDLING SECTION

Other information

store at 20–25°C (68–77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, edetate disodium, glycerin, glyceryl oleate, glyceryl stearate, lanolin, methylparaben, propyl gallate, propylene glycol, propylparaben, purified water, simethicone emulsion, sodium benzoate, sodium lauryl sulfate, stearyl alcohol, white petrolatum, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

Call weekdays from 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

PRINCIPAL DISPLAY PANEL - 26 g Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

soothing
RELIEF
anti-itch cream

HYDROCORTISONE 1%

Maximum Strength
Without a Prescription

Effective Itch Relief

No Added Fragrance

NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Label
PRINCIPAL DISPLAY PANEL - 26 g Tube Label

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

PREPARATION H ®

soothing
RELIEF
anti-itch cream

HYDROCORTISONE 1%

Maximum Strength
Without a Prescription

Effective Itch Relief

No Added Fragrance

ONE TUBE / NET WT 0.9 0Z (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
310868hydrocortisone 1 % Rectal CreamPSN7
310868hydrocortisone 10 MG/ML Rectal CreamSCD7
310868hydrocortisone 1 % Rectal CreamSY7

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
0573-0552-11PREPARATION H SOOTHING RELIEF ANTI-ITCH26 g in 1 TUBECREAM267
0573-0552-11PREPARATION H SOOTHING RELIEF ANTI-ITCH1 in 1 CARTONCREAM17

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-0552-11GM - Gram0573-055242aae87f-f65e-4bf1-b46a-db64b0671d1012022-12-07

Products#

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

DailyMed product names page 1 of 1 · 23 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-05520573-0552-11

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 22 matching rows.

Name, UNII, Kind table
NameUNIIKind
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
GLYCERYL OLEATE4PC054V79PIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
LANOLIN7EV65EAW6HIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
DIMETHICONE 3502Y53S6ATLUIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARYL ALCOHOL2KR89I4H1YIACT
PETROLATUM4T6H12BN9UIACT
XANTHAN GUMTTV12P4NEEIACT
HYDROCORTISONEWI4X0X7BPJACTIB

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
PREPARATION H SOOTHING RELIEF ANTI-ITCHHYDROCORTISONEHaleon US Holdings LLCd6148d77-ef6f-4552-b5ba-43b429923f192025-07-07WarningsExact identifier
ndc (package): 0573-0552-11
ndc (product): 0573-0552
ndc11 (package): 00573055211
spl id: 395a1c1c-351c-0fcf-e063-6394a90a3b6e
spl set id: d6148d77-ef6f-4552-b5ba-43b429923f19

Reported adverse events (FAERS/openFDA)#

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