Hemorroidal Cooling gel

Manufacturer
Trifecta Pharmaceuticals Usa Llc
Effective date
2024-12-18
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:44:40

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
  • introduction of applicator into the rectum causes additional pain

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

Trifecta Pharmaceuticals USA™

101 NE Third Avenue, Suite 1500

Ft. Lauderdale, FL. 33301, USA

1-888-296-9067

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

globe_cooling_gelglobe_cooling_gel

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69396-032-18Hemorroidal Cooling gel56 g in 1 TUBEGEL566
69396-032-18Hemorroidal Cooling gel1 in 1 BOXGEL16

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69396-032HEMORROIDAL COOLING GEL (PHENYLEPHRINE, WITCH HAZEL) GEL [TRIFECTA PHARMACEUTICALS USA LLC]6Current NDC, Legacy NDC, 2 package rows20241220_651c0143-384c-3649-e053-2991aa0a0f28.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69396-032-18GM - Gram69396-032b56c238e-12d5-496d-a7a5-5c15e601725c12018-11-06

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
69396-03269396-032-18

Ingredients#

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

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

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 HAZELTrifecta Pharmaceuticals Usa Llc651c0143-384c-3649-e053-2991aa0a0f282024-12-18WarningsExact identifier
ndc (package): 69396-032-18
ndc (product): 69396-032
ndc11 (package): 69396003218
spl id: 298d9e2d-7fff-7f15-e063-6394a90a1639
spl set id: 651c0143-384c-3649-e053-2991aa0a0f28

Reported adverse events (FAERS/openFDA)#

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