FDA.reportPublic FDA data

Hemorrhoidal Cream

Manufacturer
Cardinal Health 110, LLC. dba Leader
Effective date
2023-10-25
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-05-31 23:57:33

Label at a glance#

ProductHemorrhoidal Cream
Active ingredientPRAMOXINE HYDROCHLORIDE, GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PETROLATUM
Label structure10 sections

Indications and uses

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

Dosage and administration

Adults: Children under 12 years of age: consult a doctor. when practical, cleanse the affected area with mild soap and warm 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. apply externally or in the lower ...

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Glycerin 14.4%

Phenylephrine HCl 0.25%

Pramoxine HCl 1%

White petrolatum 15%

Purpose

OTC - PURPOSE SECTION

Protectant

Vasoconstrictor

Local anesthetic

Protectant

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only.

When using this product

OTC - WHEN USING SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Ask a doctor or pharmacist before use if you are

OTC - ASK DOCTOR/PHARMACIST SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

Adults:

Children under 12 years of age: consult a doctor.

  • when practical, cleanse the affected area with mild soap and warm 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.
  • apply externally or in the lower portion of the anal canal only.
  • for application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubricate dispensing cap well, then gently insert dispensing cap partway into the anus.

Other Information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf extract, carboxymethylcellulose sodium, cetyl alcohol, glyceryl monostearate, methylparaben, paraffin, propylene glycol, propylparaben, stearic acid, tween 80, water, xanthan gum

Questions?

OTC - QUESTIONS SECTION

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

Section Type change

RECENT MAJOR CHANGES SECTION

The section type INSTRUCTIONS FOR USE SECTION has been updated to DOSAGE & ADMINISTRATION SECTION. The information within the section stays the same.

Package type 70000-0425-1

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

70000-0425-1 inner level70000-0425-1 inner level70000-0425-1 outer level70000-0425-1 outer level

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
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
58f3f9b7-3b9b-a9c1-1c9f-18ac777192b8Product name120140508
a7051cba-790b-a699-81f8-dbbbdbd9b5acProduct name120140508
da108d9e-edc8-17a3-8c28-3251c6a8acccProduct name120140508
e949165d-714d-e548-2b76-0cb5def16f30Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0425-12023-02-14C16284748780-1f386c64a-1597-0266-e053-dadaa90a7c1aMAX STRENTH PAIN RELIEF HEMORRHOIDAL CREAM
70000-0425-12023-01-30C16284748780-1f386c64a-1597-0266-e053-dadaa90a7c1aMAX STRENTH PAIN RELIEF HEMORRHOIDAL CREAM

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0425-1Hemorrhoidal Cream1 in 1 BOXCREAM14
70000-0425-1Hemorrhoidal Cream28 g in 1 TUBECREAM284

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0425HEMORRHOIDAL CREAM (GLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUM) CREAM [CARDINAL HEALTH 110, LLC. DBA LEADER]4Current NDC, Legacy NDC, 2 package rows20231025_85a51d5c-679e-1959-e053-2a91aa0a76d5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0425-1GM - Gram70000-0425d31547e8-ac4a-44d2-8185-27838bf5b24112019-11-12

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
70000-042570000-0425-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
GLYCERYL MONOSTEARATE230OU9XXE4IACT
STEARIC ACID4ELV7Z65APIACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
XANTHAN GUMTTV12P4NEEIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
ALOE VERA LEAFZY81Z83H0XIACT
CETYL ALCOHOL936JST6JCNIACT
PARAFFINI9O0E3H2ZEIACT
PRAMOXINE HYDROCHLORIDE88AYB867L5ACTIB
GLYCERINPDC6A3C0OXACTIB
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
PETROLATUM4T6H12BN9UACTIB

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 CreamGLYCERIN, PHENYLEPHRINE HYDROCHLORIDE, PRAMOXINE HYDROCHLORIDE, WHITE PETROLATUMCardinal Health 110, LLC. dba Leader85a51d5c-679e-1959-e053-2a91aa0a76d52023-10-25WarningsExact identifier
ndc (package): 70000-0425-1
ndc (product): 70000-0425
ndc11 (package): 70000042501
spl id: 0884bc8d-70d0-80db-e063-6294a90a6582
spl set id: 85a51d5c-679e-1959-e053-2a91aa0a76d5

Reported adverse events (FAERS/openFDA)#

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