Avedana ® Hemorrhoidal Pain Relief Cream

Manufacturer
Unipack LLC
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:39:37

Label at a glance#

ProductAvedana Hemorrhoidal Maximum Strength
Active ingredientPETROLATUM, GLYCERIN, PRAMOXINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
Label structure18 sections

Indications and uses

-for temporary relief of pain, soreness, and burning. -helps relieve the local itching and discomfort associated with hemorrhoids. -temporarily shrinks hemorrhoidal tissue. -temporarily provides a coating for relief of anorectal discomforts. -temporarily protects the inflamed, irritated anorectal 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 applying cream.  When first opening the tube, puncture foil seal with top end of cap.  Apply externally or in the lower portion of the anal canal only.  Apply to the affected area up to 4 times daily, especially at night, in the mornin...

Storage and handling

store at 15ºC - 30ºC (59ºF -86ºF)

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 anasthetic

Protectant

Uses

INDICATIONS & USAGE SECTION

-for temporary relief of pain, soreness, and burning.

-helps relieve the local itching and discomfort associated with hemorrhoids.

-temporarily shrinks hemorrhoidal tissue.

-temporarily provides a coating for relief of anorectal discomforts.

-temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful.

Warnings

WARNINGS SECTION

For external 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 the 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.

When using this product

OTC - DO NOT USE SECTION

-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

Stop use and ask a doctor if

OTC - STOP USE SECTION

-bleeding occurs

-condition worsens or does not improve within 7 days

-an allergic reaction develops

-the symptom being treated does not subside or if redness, irritation, swelling pain, or other symptoms develop or increase

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.

Directions

INSTRUCTIONS FOR USE 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 applying cream.  When first opening the tube, puncture foil seal with top end of cap.  Apply externally or in the lower portion of the anal canal only.  Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.

-For application in the lower anal canal: remove cover from dispensing cap.  Attach dispensing cap to tube.  Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

-thoroughly cleanse dispensing cap after each use and replace cover.

-children under 12 years of age: ask a doctor.

Directions

DOSAGE & ADMINISTRATION SECTION

Apply externally or in the lower portion of the anal canal only. Apply to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement.

-For application in the lower anal canal: remove cover from dispensing cap. Attach dispensing cap to tube. Lubrcate dispensing cap well, then gently insert dispensing cap partway into the anus.

Other information

STORAGE AND HANDLING SECTION

store at 15ºC - 30ºC (59ºF -86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aloe barbadensis leaf extract, butylated hydroxytoluene, cetyl esters, cetyl palmitate, glyceryl monostearate, isopropyl myristate, lanolin, methylparaben, mineral oil, polysorbate 60, propylene glycol, propylparaben, sodium citrate, stearic acid, stearyl alcohol, vitamin E, water

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E Tube Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Tube Label 0.9oz

Tube Label 0.9ozTube Label 0.9oz

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 0.9 OZ (26 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

0.9oz Carton Label

Carton Label 0.9ozCarton Label 0.9oz

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 1.8 OZ (51 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.8oz Tube Label

Tube Label 1.8ozTube Label 1.8oz

Avedana Hemorrhoidal Cream ® Maximum Strength w/ Aloe & Vitamin E 1 TUBE | NET WT 1.8 OZ (51 g)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

1.8oz Carton Label

Carton Label 1.8ozCarton Label 1.8oz

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
43749-470-012026-01-29C16284748780-149896155-b8f3-586f-e063-e6dba90add90Avedana ® Hemorrhoidal Pain Relief Cream
43749-470-022026-01-29C16284748780-149896155-b8f3-586f-e063-e6dba90add90Avedana ® Hemorrhoidal Pain Relief Cream

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-470-01Avedana HemorrhoidalMaximum Strength1 in 1 CARTONCREAM16
43749-470-02Avedana HemorrhoidalMaximum Strength1 in 1 CARTONCREAM16
43749-470-03Avedana HemorrhoidalMaximum Strength25.5 g in 1 TUBECREAM25.56
43749-470-04Avedana HemorrhoidalMaximum Strength51 g in 1 TUBECREAM516

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-470AVEDANA HEMORRHOIDAL MAXIMUM STRENGTH (HEMORRHOIDAL) CREAM [UNIPACK LLC]6Legacy NDC, 4 package rows20241128_de618ae6-db79-4392-b30e-34a6bdcb1376.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-470-01GM - Gram43749-470cc3876ff-0aa1-4b72-a5d2-bd6ae706bf2712024-04-05

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43749-47043749-470-03, 43749-470-01, 43749-470-04, 43749-470-02

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 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
27ddc10a-7b90-a4be-e063-6394a90a2e47de618ae6-db79-4392-b30e-34a6bdcb13762024-11-26WarningsExact identifier
spl id: 27ddc10a-7b90-a4be-e063-6394a90a2e47
spl set id: de618ae6-db79-4392-b30e-34a6bdcb1376

Reported adverse events (FAERS/openFDA)#

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