FDA.reportPublic FDA data

CVS HEALTH ™ HEMORRHOIDAL COOLING GEL HEMORRHOIDAL GEL

Manufacturer
CVS | Natureplex LLC
Effective date
2022-11-18
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:51:46

Label at a glance#

ProductCVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL
Label structure10 sections

Indications and uses

temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas temporary relief of burning

Dosage and administration

Adults when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel apply externally to affected area up to 4 times daily or after each bowel movement Children under 12 years old: Ask a doctor.

Storage and handling

store at 15 to 30°C (59 to 86°F) Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredientsPurpose
Hamamelis virginiana (witch hazel) 50%Astringent
Phenylephrine hydrochloride 0.25%Vasoconstrictor

Uses

INDICATIONS & USAGE SECTION

  • temporarily relieves anorectal itching and discomfort associated with hemorrhoids or anorectal disorders
  • temporarily reduces the swelling associated with irritation in hemorrhoids and other anorectal disorders
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas
  • temporary relief of burning

Warnings

WARNINGS SECTION

For external use only.

OTC - DO NOT USE SECTION

Do not use this product

  • if you have heart disease, high blood pressure, thyroid disease, diabetes, or difficulty in urination due to enlargement of the prostate gland unless directed by a doctor.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are

  • presently taking a prescription drug for high blood pressure or depression

When using this product

OTC - WHEN USING SECTION

  • do not exceed recommended daily dosage unless directed by a doctor
  • do not put into rectum by using fingers or any mechanical device or applicator

OTC - STOP USE SECTION

Stop use and ask a doctor if

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

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: 800-222-1222.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults

  • when practical, cleanse affected area by patting or blotting with appropriate cleansing wipe. Gently dry by patting or blotting with tissue or soft cloth before applying gel
  • apply externally to affected area up to 4 times daily or after each bowel movement

Children under 12 years old: Ask a doctor.

Other information

STORAGE AND HANDLING SECTION

  • store at 15 to 30°C (59 to 86°F)
  • Tamper Evident: DO NOT USE IF SEAL ON TUBE IS PUNCTURED OR MISSING.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, benzophenone-4, disodium EDTA, hydroxyethylcellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

OTC - QUESTIONS SECTION

Questions or comments?

866-323-0107

SPL UNCLASSIFIED SECTION

Distributed by:
CVS Pharmacy, Inc.
One CVS Drive
Woonsocket, RI 02895

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS
Health®

Compare to the active
ingredients in Preparation H®
Cooling Gel*

NDC 69842-843-01

Hemorrhoidal
Cooling Gel

FAST COOLING RELIEF

  • Clear, non-greasy formula
    with soothing aloe & a
    pleasant scent
  • Shrinks swollen
    hemorrhoidal tissue
  • Prompt cooling relief from
    painful burning & itching
  • Relieves external discomfort

Package Contains
One Tube

NET WT 0.9 OZ (26 g)

PRINCIPAL DISPLAY PANEL - 26 g Tube Carton
PRINCIPAL DISPLAY PANEL - 26 g Tube Carton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN3
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD3
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY3

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
f489e8f3-5c9e-4818-b539-a73587edcfc7Product name220240229
0f7ae452-206d-4fc4-868d-56fc47074084Product name120231011
b5abe2e3-39a1-43eb-9bff-f3c1653fe3dfProduct name220190930
e0b6c8be-f2bd-9f86-a9fc-3ed56ffaa814Product name320150910
42f3c020-f1b3-89bc-7bdc-e1f10e680485Product name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
69842-843-012025-01-30C16284748780-12cef2736-8260-d83d-e063-dadaa90ab31fCVS HEALTH ™ HEMORRHOIDAL COOLING GEL HEMORRHOIDAL GEL

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-843-01CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL26 g in 1 TUBEGEL263
69842-843-01CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL1 in 1 CARTONGEL13

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69842-843CVS HEALTH HEMORRHOIDAL COOLING HEMORRHOIDAL (PHENYLEPHRINE HYDROCHLORIDE AND WITCH HAZEL) GEL [CVS]3Legacy NDC, 2 package rows20221123_94e0b160-b557-4f33-8855-345c8b40e9eb.zip

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-84369842-843-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WITCH HAZEL101I4J0U34ACTIB
ALOE VERA LEAFZY81Z83H0XIACT
SULISOBENZONE1W6L629B4KIACT
EDETATE DISODIUM ANHYDROUS8NLQ36F6MMIACT
HYDROXYETHYL CELLULOSE (100 MPA.S AT 2%)R33S7TK2EPIACT
METHYLPARABENA2I8C7HI9TIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT

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
ba6f8a55-3732-42a1-8f49-40c4f05225f094e0b160-b557-4f33-8855-345c8b40e9eb2022-11-18WarningsExact identifier
spl id: ba6f8a55-3732-42a1-8f49-40c4f05225f0
spl set id: 94e0b160-b557-4f33-8855-345c8b40e9eb

Reported adverse events (FAERS/openFDA)#

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