FDA.reportPublic FDA data

Preparation H Rapid Relief

Manufacturer
Haleon US Holdings LLC | Pf Soins De Sant? Sri
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 Rapid Relief
Active ingredientPETROLATUM, PHENYLEPHRINE HYDROCHLORIDE, GLYCERIN, LIDOCAINE
Label structure9 sections

Storage and handling

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

Label contents#

Full prescribing information#

Active Ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 14.4%

Lidocaine 5%

Phenylephrine HCl 0.25%

White petrolatum 15%

Purposes

OTC - PURPOSE SECTION

Protectant

Local anesthetic

Vasoconstrictor

Protectant

INDICATIONS & USAGE SECTION

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily shrinks hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed irritated anorectal surface to help make bowel movements less painful

WARNINGS SECTION

Warnings

For external use only

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty in urination due to enlargement of the prostate gland

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

OTC - WHEN USING SECTION

When using this product

  • 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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding,ask a health professional before use.

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 a soft cloth before applying this cream.
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor

STORAGE AND HANDLING SECTION

Other information

store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

OTC - QUESTIONS SECTION

Questions or comments?

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

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H ®

New Benefit
Now Reduces Swelling
See new label

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL
CREAM

LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN
WHITE PETROLATUM

5%
HIGHEST STRENGTH
LIDOCAINE
AVAILABLE

  • Rapid numbing relief of pain,
    itching & burning
  • Reduces swelling & provides
    a soothing protective layer

1 TUBE | NET WT 0.75 OZ (23 g)

Preparation H Rapid Relief w PE 0.75 oz
Preparation H Rapid Relief w PE 0.75 oz

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamPSN8
2642220glycerin 144 MG/ML / lidocaine 50 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal CreamSCD8
2642220glycerin 14.4 % / lidocaine 5 % / phenylephrine HCl 0.25 % / white petrolatum 15 % Rectal CreamSY8

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
GLYCERIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
LIDOCAINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PHENYLEPHRINE Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
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860a93dc-4863-49cc-b284-6bbe8191bc48Product name420250214
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f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2843-01Preparation H Rapid Relief23 g in 1 TUBECREAM238
0573-2843-01Preparation H Rapid Relief1 in 1 CARTONCREAM18
0573-2843-10Preparation H Rapid Relief28 g in 1 TUBECREAM288
0573-2843-10Preparation H Rapid Relief1 in 1 CARTONCREAM18

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2843PREPARATION H RAPID RELIEF (GLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDE) CREAM [HALEON US HOLDINGS LLC]8Current NDC, Legacy NDC, 4 package rows20240302_699310e8-1a93-40b4-a8f4-a765be4a0cb1.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2843-01GM - Gram0573-2843e8f6f5a6-9a57-4020-b4e8-edb469fbaf1212022-12-07
0573-2843-10GM - Gram0573-28432135f3a4-625f-4979-9d61-4bee9eab223b12024-02-14

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-28430573-2843-01, 0573-2843-10

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 27 matching rows.

Name, UNII, Kind table
NameUNIIKind
PETROLATUM4T6H12BN9UACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
BUTYLATED HYDROXYANISOLEREK4960K2UIACT
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIEDK679OBS311IACT
CETYL ALCOHOL936JST6JCNIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
DEXPANTHENOL1O6C93RI7ZIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
METHYLPARABENA2I8C7HI9TIACT
MINERAL OILT5L8T28FGPIACT
LAURETH-23N72LMW566GIACT
STEARETH-2V56DFE46J5IACT
STEARETH-20L0Q8IK9E08IACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARYL ALCOHOL2KR89I4H1YIACT
TOCOPHEROLR0ZB2556P8IACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
XANTHAN GUMTTV12P4NEEIACT
GLYCERINPDC6A3C0OXACTIB
LIDOCAINE98PI200987ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

Source Document#

Source XML · Source PDF

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 Rapid ReliefGLYCERIN, LIDOCAINE, PETROLATUM, AND PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC699310e8-1a93-40b4-a8f4-a765be4a0cb12024-02-29WarningsExact identifier
ndc (package): 0573-2843-10
ndc (package): 0573-2843-01
ndc (product): 0573-2843
ndc11 (package): 00573284310
ndc11 (package): 00573284301
spl id: 12914c05-4ec9-4077-e063-6294a90ac86a
spl set id: 699310e8-1a93-40b4-a8f4-a765be4a0cb1

Reported adverse events (FAERS/openFDA)#

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