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

Key Label Information#

Active Ingredients And Purpose

Active ingredients

Phenylephrine HCl 0.25% Witch hazel 50.0%

Purposes

Vasoconstrictor Astringent

Uses

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

Warnings

Warnings

For external use only

Directions And Dosage

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 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 Label Information

Inactive ingredients

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?

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

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

Label Images#

PAA162794 PrepH Cooling Gel 1.8 oz (51 g).jpg
PAA162794 PrepH Cooling Gel 1.8 oz (51 g).jpg

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#

NDC Codes#

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

Ingredients#

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

Complete SPL Sections#

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

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 1-800-99PrepH or 1-800-997-7374

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

Source Document#

Source XML