Indications and 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
PREPARATION H HYDROCORTISONE
- Manufacturer
- Haleon US Holdings LLC
- Effective date
- 2024-02-29
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 00:09:17
Label at a glance#
ProductPREPARATION H HYDROCORTISONE
Active ingredientHYDROCORTISONE
Label structure9 sections
Dosage and administration
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 ...
Contacts and useful links#
Label contents#
Full prescribing information#
ACTIVE INGREDIENT
Hydrocortisone 1%
PURPOSE
Anti-itch
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
For external use only
Do not use
for the treatment of diaper rash. Consult a doctor.
When using this product
- 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
- 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.
Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.
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
OTHER INFORMATION
store at 20-25°C (68-77°F)
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
QUESTIONS OR COMMENTS?
Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374.
PRINCIPAL DISPLAY PANEL
NDC 0573-2830-11
New Look,
SAME SIZE!
PREPARATION H ®
HYDROCORTISONE 1%
ANTI-ITCH
CREAM
Relieves
the Itch
- Maximum StrengthWithout
a Prescription - Effective Relief of Anal Itch
- Doctor-Prescribed Ingredient
1 TUBE | NET WT 0.9 OZ (26 g)
DailyMed RxNorm Mappings#
DailyMed Pharmacologic Classes#
| Class | Version | Type | Effective |
|---|---|---|---|
| HYDROCORTISONE Pharmacologic Class Indexing | 2 | Indexing - Pharmacologic Class | 20180813 |
DailyMed Product Concepts#
FDA-Initiated Inactive NDC Indexing#
| NDC | Effective | Action | Document | Indexing SPL | Related label |
|---|---|---|---|---|---|
| 0573-2830-10 | 2024-02-29 | C162847 | 48780-1 | d6a99b39-9920-a426-e053-dadaa90af4c2 | Drug Facts |
| 0573-2830-10 | 2022-01-28 | C162847 | 48780-1 | d6a99b39-9920-a426-e053-dadaa90af4c2 | Drug Facts |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0573-2830-10 | PREPARATION H HYDROCORTISONE | 1 in 1 CARTON | CREAM | 1 | 8 | |
| 0573-2830-10 | PREPARATION H HYDROCORTISONE | 26 g in 1 TUBE | CREAM | 26 | 8 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0573-2830-10 | GM - Gram | 0573-2830 | 0965d4da-363e-4cde-8b54-fac02b9c7bb4 | 1 | 2012-07-24 |
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| hydrocortisone | ACTIVE INGREDIENT | WI4X0X7BPJ | 3 | |
| hydrocortisone | ACTIVE MOIETY | WI4X0X7BPJ | 3 |
Products#
Every source-derived product name is available through these pages.
- PREPARATION H HYDROCORTISONE
- hydrocortisone
- ANHYDROUS CITRIC ACID
- BUTYLATED HYDROXYANISOLE
- CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED
- CETYL ALCOHOL
- CITRIC ACID MONOHYDRATE
- EDETATE DISODIUM
- GLYCERIN
- GLYCERYL OLEATE
- GLYCERYL MONOSTEARATE
- LANOLIN
- METHYLPARABEN
- PROPYL GALLATE
- PROPYLENE GLYCOL
- PROPYLPARABEN
- WATER
- DIMETHICONE 350
- SODIUM BENZOATE
- SODIUM LAURYL SULFATE
- STEARYL ALCOHOL
- PETROLATUM
- XANTHAN GUM
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0573-2830 | 0573-2830-10 |
Ingredients#
Every source-derived ingredient row is available through these pages.
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| PREPARATION H HYDROCORTISONE | HYDROCORTISONE | Haleon US Holdings LLC | b8d531eb-4012-0450-0e4b-70a808464041 | 2024-02-29 | Warnings | 0573-2830-10 0573-2830 00573283010 128ad543-e543-6322-e063-6294a90a2743 b8d531eb-4012-0450-0e4b-70a808464041 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.