FDA.reportPublic FDA data

Preparation H Cooling Gel

Manufacturer
Haleon US Holdings LLC
Effective date
2024-04-05
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:10:43

Label at a glance#

ProductPreparation H Cooling Gel
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL
Label structure9 sections

Indications and uses

helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas

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 a soft cloth before applying gel. when first opening the tube, puncture foil seal with top end of cap 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:...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Purposes

OTC - PURPOSE SECTION

Vasoconstrictor

Astringent

Uses

INDICATIONS & USAGE SECTION

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas

Warnings

WARNINGS SECTION

For external use only

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

presently 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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • bleeding occurs
  • condition worsens or does not improve within 7 days

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 gel.
  • when first opening the tube, puncture foil seal with top end of cap
  • 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

Other information

SPL UNCLASSIFIED SECTION

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E acetate

Questions or comments?

OTC - QUESTIONS SECTION

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

Additional information

SPL UNCLASSIFIED SECTION

Do Not Use if tube seal under cap embossed with “H” is broken or missing.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK

©2021 GSK or licensor

Made In Canada

Do Not Use if tube seal under cap embossed with “H” is broken or missing.

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATION H

HEMORRHOIDAL
COOLING
GEL

Fast Cooling
Relief

  • Clear, Non-Greasy Formula with
    No Unpleasant Scent
  • Prompt, Cooling Relief from Painful
    Burning & Itching
  • Shrinks Swollen Hemorrhoidal Tissue
  • Relieves External Discomfort

1 TUBE | NET WT 1.8 OZ (51 g)

PAA162794 Front Carton

PrepH Cooling Gel 1.8 oz (51 g)
PrepH Cooling Gel 1.8 oz (51 g)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN9
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD9
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY9

DailyMed Pharmacologic Classes#

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
0573-2840-102022-12-14C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug Facts
0573-2840-202022-12-14C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug Facts
0573-2840-102022-01-28C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug Facts
0573-2840-202022-01-28C16284748780-1d6a99b39-b442-a426-e053-dadaa90af4c2Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-2840-10Preparation H Cooling Gel26 g in 1 TUBEGEL269
0573-2840-10Preparation H Cooling Gel1 in 1 CARTONGEL19
0573-2840-20Preparation H Cooling Gel1 in 1 CARTONGEL19
0573-2840-20Preparation H Cooling Gel51 g in 1 TUBEGEL519

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-2840PREPARATION H COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [HALEON US HOLDINGS LLC]9Current NDC, Legacy NDC, 4 package rows20240406_cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0573-2840-10GM - Gram0573-2840644c6680-7646-486f-8f54-c5a0059b4d7912014-01-04
0573-2840-20GM - Gram0573-284096323852-5702-424d-99f5-98a7dc99da5512012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
phenylephrine hydrochlorideACTIVE INGREDIENT04JA59TNSJ3
witch hazelACTIVE INGREDIENT101I4J0U343
phenylephrineACTIVE MOIETY1WS297W6MV3
witch hazelACTIVE MOIETY101I4J0U343

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-28400573-2840-10, 0573-2840-20

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SULISOBENZONE1W6L629B4KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WITCH HAZEL101I4J0U34ACTIB

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 Cooling GelPHENYLEPHRINE HCL, WITCH HAZELHaleon US Holdings LLCcebee3f7-8591-e4f7-e66a-e43b4ba3aaf42024-04-05WarningsExact identifier
ndc (package): 0573-2840-20
ndc (package): 0573-2840-10
ndc (product): 0573-2840
ndc11 (package): 00573284010
ndc11 (package): 00573284020
spl id: 15581b30-e802-550a-e063-6394a90a3aae
spl set id: cebee3f7-8591-e4f7-e66a-e43b4ba3aaf4