FDA.reportPublic FDA data

Preparation H Rapid Relief

Manufacturer
Haleon US Holdings LLC
Effective date
2024-02-29
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:09:16

Label at a glance#

ProductPreparation H Rapid Relief
Active ingredientLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE
Label structure10 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

Lidocaine 5%

Phenylephrine HCl 0.25%

Purposes

OTC - PURPOSE SECTION

Local anesthetic

Vasoconstrictor

INDICATIONS & USAGE SECTION

Uses

  • Helps relieve the local discomfort and itching associated with hemorrhoids
  • For the temporary relief of pain, soreness or burning
  • Temporarily reduces the swelling associated with irritation in hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue

WARNINGS SECTION

Warnings

For external use only

Flammable:Do not use while smoking or near heat or flame

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • 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.

When using this product

OTC - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
  • Warning -avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
  • Warning -use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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 pad
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • Shake well before using
  • Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
  • Apply externally to the affected area up to 4 times daily
  • Children under 12 years of age: consult a doctor

STORAGE AND HANDLING SECTION

Other information

  • Store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredients

aloe barbadensis leaf juice, citric acid, disodium EDTA, glycerin, isobutane, malic acid, menthol, propyl gallate, propylene glycol, SD alcohol 40-B, sodium benzoate, water

OTC - QUESTIONS SECTION

Questions or comments?

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

Additional Information

SPL UNCLASSIFIED SECTION

No-Touch Spray

Do not use if clear safety seal around cap is broken or missing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

@2021 GSK or licensor

For most recent product information, visit www.preparationh.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NEW!

PREPARATIONH

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL SPRAY

LIDOCAINE
PHENYLEPHRINE HCl

  • Rapid numbing relief of pain,

    itching and burning

  • Reduces swelling of
    inflamed tissue
  • Highest strength lidocaine

    available

NET WT 3.8 OZ (107.7 g)

000070918 Front Label

PrepH Relief Spray with Lidocaine 3.8 oz(107.7 g)
PrepH Relief Spray with Lidocaine 3.8 oz(107.7 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2590656lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal SprayPSN2
2590656lidocaine 50 MG/ML / phenylephrine hydrochloride 2.5 MG/ML Rectal SpraySCD2
2590656lidocaine 5 % / phenylephrine hydrochloride 0.25 % Rectal SpraySY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
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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ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
7d755fa1-1087-4dcd-98f0-6d4bba479a57Product name320210602
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b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
fa8b5901-e681-426f-82fe-54f6d81ec698Product name420180619
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
332d03e4-aa24-4b11-841a-02bf41081920Product name120171221
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252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2890-01Preparation H Rapid Relief107.7 g in 1 CANISTERSPRAY107.72
0573-2890-02Preparation H Rapid Relief127.6 g in 1 CANISTERSPRAY127.62

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2890PREPARATION H RAPID RELIEF (LIDOCAINE, PHENYLEPHRINE HYDROCHLORIDE) SPRAY [HALEON US HOLDINGS LLC]2Current NDC, Legacy NDC, 2 package rows20240302_27db1d58-4609-4a80-af2f-9e36f10482e1.zip

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-28900573-2890-01, 0573-2890-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
ISOBUTANEBXR49TP611IACT
MALIC ACID817L1N4CKPIACT
MENTHOL, UNSPECIFIED FORML7T10EIP3AIACT
PROPYL GALLATE8D4SNN7V92IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ALCOHOL3K9958V90MIACT
SODIUM BENZOATEOJ245FE5EUIACT
WATER059QF0KO0RIACT
LIDOCAINE98PI200987ACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB

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 Rapid ReliefLIDOCAINE, PHENYLEPHRINE HYDROCHLORIDEHaleon US Holdings LLC27db1d58-4609-4a80-af2f-9e36f10482e12024-02-29WarningsExact identifier
ndc (package): 0573-2890-02
ndc (package): 0573-2890-01
ndc (product): 0573-2890
ndc11 (package): 00573289001
ndc11 (package): 00573289002
spl id: 128be2b3-36d1-2aad-e063-6394a90ab198
spl set id: 27db1d58-4609-4a80-af2f-9e36f10482e1

Reported adverse events (FAERS/openFDA)#

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