CVS Health Hemorrhoidal Cream, 28g

Manufacturer
FRONT PHARMACEUTICAL PLC
Effective date
2023-10-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:58:06

Label at a glance#

ProductCVS Health Hemorrhoidal Cream
Active ingredientGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, PETROLATUM
Label structure10 sections

Storage and handling

store at room temperature 68° - 77° F (20° -  25° C) Other information

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

OTC - PURPOSE SECTION

Purpose

Glycerin 14.4% ...........................Protectant

Phenylephrine HCl 0.25% .............Vasoconstrictor

Pramoxine HCl 1%........................Local anesthetic

White petrolatum 15%..................Protectant

INDICATIONS & USAGE SECTION

•for temporary relief of pain, soreness and burning •helps relieve Uses 

the local itching and discomfort associated ith hemorrhoids

•temporarily provides a coating for f of anorectal discomforts

•temporarily protects the inflamed irritated anorectal surface to help make

bowel movements less painful  •temporarily shrinks hemorrhoidal tissue

WARNINGS SECTION

Warnings

. For external use only

•do not put this product into the rectum by When using this product

using fingers or any mechanical device or applicator •do not exceed

recommended daily dosage unless directed by a doctor

Ask a doctor before use ifyou have

•heart disease •high blood pressure •thyroid disease •diabetes

•trouble urinating due to an enlarged prostate gland

presently taking a Ask a doctor or pharmacist before use if you are

prescription drug for high blood pressure or depsression

Stop use and ask a doctor if

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

•if the symptoms being treated do not subside or if redness, irritation,

swelling, pain or other symptoms develop or increase. Some people can

develop allergic reactions to ingredients in this product.

, ask a health professional before use. If pregnant or breast-feeding

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

. If swallowed, get medical help or contact Keep out of reach of children

a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

Adults: Directions

•when practical, cleanse the affected area with mild soap and water and rinse thoroughly.

Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product.

•apply externally to the affected area up to 4 times daily, especially at night or in the

morning or after each bowel movement.

Children under 12 years of age: consult a doctor.

STORAGE AND HANDLING SECTION

store at room temperature 68° - 77° F (20° -  25° C) Other information

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, carboxymethyllcellulose Inactive ingredients

sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene

glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

OTC - QUESTIONS SECTION

1-800-639-3803 Weekdays 9 AM to 4 PM EST Questions?

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1293649glycerin 14.4 % / phenylephrine HCl 0.25 % / pramoxine HCl 1 % / white petrolatum 15 % Rectal CreamPSN4
1293649glycerin 144 MG/ML / petrolatum 150 MG/ML / phenylephrine hydrochloride 2.5 MG/ML / pramoxine hydrochloride 10 MG/ML Rectal CreamSCD4
1293649glycerin 14.4 % / phenylephrine hydrochloride 0.25 % / pramoxine hydrochloride 1 % / white petrolatum 15 % Rectal CreamSY4

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69571-010-28CVS Health Hemorrhoidal Cream1 in 1 BOXCREAM14
69571-010-28CVS Health Hemorrhoidal Cream28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69571-010CVS HEALTH HEMORRHOIDAL CREAM (GLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUM) CREAM [FRONT PHARMACEUTICAL PLC]4Current NDC, Legacy NDC, 2 package rows20231027_cb448d78-553c-4e65-80c5-d4b31d7b3661.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69571-01069571-010-28

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 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
CVS Health Hemorrhoidal CreamGLYCERIN, PHENYLEPHRINE HCL, PRAMOXINE HCL, WHITE PETROLATUMFRONT PHARMACEUTICAL PLCcb448d78-553c-4e65-80c5-d4b31d7b36612023-10-26WarningsExact identifier
ndc (package): 69571-010-28
ndc (product): 69571-010
ndc11 (package): 69571001028
spl id: 08a1a1e3-05bb-5508-e063-6294a90a8fa0
spl set id: cb448d78-553c-4e65-80c5-d4b31d7b3661

Reported adverse events (FAERS/openFDA)#

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