FDA.reportPublic FDA data

Avedana HEMORRHOIDAL COOLING Gel

Manufacturer
Unipack LLC
Effective date
2024-02-28
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:09:13

Label at a glance#

ProductAvedana HEMORRHOIDAL COOLING Gel
Active ingredientPHENYLEPHRINE HYDROCHLORIDE, WITCH HAZEL
Label structure10 sections

Indications and uses

helps relieve the local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning temporarily shrinks hemorrhoidal tissue aids in protecting irritated anorectal areas

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 gel. when first opening the tube, puncture foil seal with top end of cap apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement children under 12 years of age:...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Phenylephrine HCl 0.25%

Witch hazel 50.0%

PURPOSES

OTC - PURPOSE SECTION

Vasoconstrictor

Astringent

USES

INDICATIONS & USAGE SECTION

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • temporarily shrinks hemorrhoidal tissue
  • aids in protecting irritated anorectal areas

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 - WHEN USING SECTION

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product 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

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

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 applying gel.
  • when first opening the tube, puncture foil seal with top end of cap
  • apply externally to the affected area up to 4 times daily, especially at night, in the morning or after each bowel movement
  • children under 12 years of age: ask a doctor

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

store at 15°C - 30°C (59°F - 89°F)

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E 

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

Call weekdays 8 AM to 5 PM EST at 1-724-733-7381

PRINCIPAL DISPLAY PANEL - TUBE LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Avedana®

HEMORRHOIDAL COOLING GEL

Fast Cooling
Relief

•Clear, Non-Greasy Formula with
No Unpleasant Scent•Prompt, Cooling Relief from Painful
Burning & Itching•Shrinks Swollen Hemorrhoidal Tissue•Relieves External Discomfort

1 TUBE | 25.5 g | THIS PACKAGE CONTAINS AN OUTER CARTON. DO NOT BUY IF OUTER CARTON IS MISSING.

PRINCIPAL DISPLAY PANEL - 25.5 g Tube LabelPRINCIPAL DISPLAY PANEL - 25.5 g Tube Label

PRINCIPAL DISPLAY PANEL - CARTON LABEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Avedana ®

HEMORRHOIDAL COOLING GEL

Fast Cooling
Relief

•Clear, Non-Greasy Formula with
No Unpleasant Scent•Prompt, Cooling Relief from Painful
Burning & Itching•Shrinks Swollen Hemorrhoidal Tissue•Relieves External Discomfort

1 TUBE INSIDE CARTON | NET WT 0.9 OZ (25.5 g)

PRINCIPAL DISPLAY PANEL - 25.5 g Carton LabelPRINCIPAL DISPLAY PANEL - 25.5 g Carton Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
249465phenylephrine HCl 0.25 % / witch hazel 50 % Rectal GelPSN4
249465phenylephrine 0.0025 MG/MG / witch hazel 0.5 MG/MG Rectal GelSCD4
249465phenylephrine 0.25 % / witch hazel 50 % Rectal GelSY4

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
43749-450-01Avedana HEMORRHOIDAL COOLING Gel1 in 1 CARTONGEL14
43749-450-01Avedana HEMORRHOIDAL COOLING Gel25.5 g in 1 TUBEGEL25.54

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-450AVEDANA HEMORRHOIDAL COOLING GEL (PHENYLEPHRINE HCL, WITCH HAZEL) GEL [UNIPACK LLC]4Legacy NDC, 2 package rows20240301_6e7f5b1f-5124-45cd-829d-ed7d940c2b60.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
43749-450-01GM - Gram43749-45098a07661-ff2e-4263-9aab-dc4677f1233512024-04-05

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
43749-45043749-450-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
EDETATE DISODIUM7FLD91C86KIACT
HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)8136Y38GY5IACT
METHYLPARABENA2I8C7HI9TIACT
POLYSORBATE 806OZP39ZG8HIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
WATER059QF0KO0RIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SULISOBENZONE1W6L629B4KIACT
.ALPHA.-TOCOPHEROL ACETATE9E8X80D2L0IACT
PHENYLEPHRINE HYDROCHLORIDE04JA59TNSJACTIB
WITCH HAZEL101I4J0U34ACTIB

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
12768f81-2ac0-74d4-e063-6294a90ae79e6e7f5b1f-5124-45cd-829d-ed7d940c2b602024-02-28WarningsExact identifier
spl id: 12768f81-2ac0-74d4-e063-6294a90ae79e
spl set id: 6e7f5b1f-5124-45cd-829d-ed7d940c2b60

Reported adverse events (FAERS/openFDA)#

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