FDA.reportPublic FDA data

Hemorroidal Cooling gel

Manufacturer
Pharmacy Value Alliance, LLC | Trifecta Pharmaceuticals USA LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:47:33

Label at a glance#

ProductHemorroidal Cooling gel
Active ingredientWITCH HAZEL, PHENYLEPHRINE HYDROCHLORIDE
Label structure15 sections

Indications and uses

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

Dosage and administration

Children under 12 years of age; ask a doctor before use Adults: when practical, clean 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 applying when first opening tube, remove foil seal apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCI 0.25%

Purpose

OTC - PURPOSE SECTION

Vasoconstrictor

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch Hazel 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

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

Stop use and ask a doctor

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 doctor before use

Keep out of the reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

Children under 12 years of age; ask a doctor before use

Adults: when practical, clean 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 applying
  • when first opening tube, remove foil seal
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement

Warnings

WARNINGS SECTION

For External Use Only

Ask doctor before use if you have

  • heart disease
  • high blood pressure
  • thyroid disease
  • diabetes
  • difficulty urinating due to an enlarged prostate gland

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

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

Other information

SPL UNCLASSIFIED SECTION

Store at room temperature 20°-25°C (68°-77°F)

Do not use if tube seal under cap is broken or missing

** This product is not manufactured or distributed by Wyeth Consumer Healthcare Inc. owner of the registered trademark Preparation H®

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis gel, benzophenone-4, Acetate disodium, Hydroxyethylcellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, sodium citrate, Vitamin E, water

Questions or Comments

OTC - QUESTIONS SECTION

Call Toll Free 1-888-296-9067

Distributed By

SPL UNCLASSIFIED SECTION

Premier Value Alliance, LLC.

407 East Lancaster Avenue

Wayne, PA. 19087 USA

Product of PRC

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Hemorrhoidal Cooling Gel

premier value cooling gel@3x-50premier value cooling gel@3x-50

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e4e263da-1c53-440f-bb80-b7a575843b5aProduct name120260313
d2168cac-a261-415a-9c78-3522859fa720Product name320251124
05a8cdd1-eeb8-409e-b938-0778225eca7dProduct name420250221
e5b5c132-b15d-435b-9faa-2f74e5cadcf9Product name820250220
777d68c6-a5ab-e06c-d314-677b0b9af0c8Product name220240508
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-054-092023-05-09C16284748780-1ba0f9c33-41d3-a910-e053-dadaa90a0b85Hemorrhoidal Cooling Gel
68016-054-092023-01-30C16284748780-1ba0f9c33-41d3-a910-e053-dadaa90a0b85Hemorrhoidal Cooling Gel
68016-054-092021-10-26C16284748780-1ba0f9c33-41d3-a910-e053-dadaa90a0b85Hemorrhoidal Cooling Gel
68016-054-092021-01-29C16284748780-1ba0f9c33-41d3-a910-e053-dadaa90a0b85Hemorrhoidal Cooling Gel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-054-09Hemorroidal Cooling gel1 in 1 BOXGEL14
68016-054-09Hemorroidal Cooling gel26 g in 1 TUBEGEL264

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-054HEMORROIDAL COOLING GEL (PHENYLEPHRINE, WITCH HAZEL) GEL [PHARMACY VALUE ALLIANCE, LLC]4Current NDC, Legacy NDC, 2 package rows20241222_7276aab8-0297-2a55-e053-2a91aa0a8d21.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
68016-05468016-054-09

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
POLYSORBATE 806OZP39ZG8HIACT
METHYLPARABENA2I8C7HI9TIACT
SULISOBENZONE1W6L629B4KIACT
EDETATE DISODIUM7FLD91C86KIACT
ALOE VERA LEAFZY81Z83H0XIACT
WATER059QF0KO0RIACT
SODIUM CITRATE1Q73Q2JULRIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
.ALPHA.-TOCOPHEROL ACETATE, D-A7E6112E4NIACT
PROPYLPARABENZ8IX2SC1OHIACT
HYDROXYETHYL CELLULOSE (2000 CPS AT 1%)S38J6RZN16IACT
WITCH HAZEL101I4J0U34ACTIB
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
Hemorroidal Cooling gelPHENYLEPHRINE, WITCH HAZELPharmacy Value Alliance, LLC7276aab8-0297-2a55-e053-2a91aa0a8d212024-12-20WarningsExact identifier
ndc (package): 68016-054-09
ndc (product): 68016-054
ndc11 (package): 68016005409
spl id: 29b73242-ddd9-37e0-e063-6394a90a7da9
spl set id: 7276aab8-0297-2a55-e053-2a91aa0a8d21

Reported adverse events (FAERS/openFDA)#

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