Hemorrhoidal cocoa butter

Manufacturer
NeilMed Pharmaceuticals Inc.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:56

Label at a glance#

ProductHemorrhoidal cocoa butter
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, COCOA BUTTER
Label structure15 sections

Indications and uses

• helps relieve the local itching and discomfort associated with hemorrhoids • temporarily relieves burning and shrinks hemorrhoidal tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritatedanorectal surface to help make bowel movements less painful.

Dosage and administration

• 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 insertion of this product. • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows: • hold suppository with rounded end • see illustrations; carefully separate foil tabs by inserting...

Storage and handling

store at 20° - 25°C (68° - 77°F)

Label contents#

Full prescribing information#

Drug Facts : Active Ingredients (in each suppository) :

OTC - ACTIVE INGREDIENT SECTION

Cocoa butter 88.44%

Phenylephrine Hydrochloride 0.25%

Purpose

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Uses:

INDICATIONS & USAGE SECTION

• helps relieve the local itching and discomfort associated with hemorrhoids • temporarily relieves burning and shrinks hemorrhoidal tissue • temporarily provides a coating for relief of anorectal discomforts • temporarily protects the inflamed, irritatedanorectal surface to help make bowel movements less painful.

Warnings:

WARNINGS SECTION

For rectal use only

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

• heart disease • high blood pressure • thyroid disease • diabetes • difficulty in urination due to enlargement of prostate gland unless directed by a doctor

Ask a doctor or pharmacist before use

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 the recommended daily dosage unless directed by a doctor
• children under 12 years of age: ask a doctor

Stop use and ask doctor if

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 health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical
help or contact a Poison Control Center right away. (1-800-222-1222)

Other information:

STORAGE AND HANDLING SECTION

store at 20° - 25°C (68° - 77°F)

Inactive ingredients:

INACTIVE INGREDIENT SECTION

methylparaben, propylparaben, topical starch

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 insertion of this product. • detach one suppository from the strip; remove the foil wrapper before inserting into the rectum as follows:

• hold suppository with rounded end • see illustrations; carefully separate foil tabs by inserting tip of fingernail at end marked “peel
down” • slowly and evenly peel apart (do not tear) foil by pulling tabs down both sides, to expose the suppository • remove exposed
suppository from wrapper • insert one suppository into the rectum up to 4 times daily, especially at night, in the morning or after each
bowel movement.

INTENDED USE OF THE DEVICE

Shrinks Swollen Tissue
• Reduces internal swelling, soothes & protects
• Gives prompt relief from the painful burning, itching & discomfort from hemorrhoids on a temporary basis

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Suppositories 24countSuppositories 24count

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositoryPSN2
1438497cocoa butter 0.884 MG/MG / phenylephrine hydrochloride 0.0025 MG/MG Rectal SuppositorySCD2
1438497cocoa butter 88.4 % / phenylephrine HCl 0.25 % Rectal SuppositorySY2

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-323-01Hemorrhoidal cocoa butter6 in 1 BLISTER PACKSUPPOSITORY62
13709-323-01Hemorrhoidal cocoa butter4 in 1 CARTONSUPPOSITORY42

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-323HEMORRHOIDAL COCOA BUTTER (HEMORRHOIDAL) SUPPOSITORY [NEILMED PHARMACEUTICALS INC.]2Current NDC, 2 package rows20250119_03b159b0-b960-b38d-e063-6394a90a9462.zip

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-32313709-323-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 5 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
Hemorrhoidal cocoa butterHEMORRHOIDALNeilMed Pharmaceuticals Inc.03b159b0-b960-b38d-e063-6394a90a94622025-01-17WarningsExact identifier
ndc (package): 13709-323-01
ndc (product): 13709-323
ndc11 (package): 13709032301
spl id: 2beb0548-764d-eb34-e063-6294a90a64d9
spl set id: 03b159b0-b960-b38d-e063-6394a90a9462

Reported adverse events (FAERS/openFDA)#

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