Avedana ® - DailyMed Details

Avedana ®

SPL v4

SPL

SPL Set ID 6e7f5b1f-5124-45cd-829d-ed7d940c2b60

Route

TOPICAL

Published

Effective Date 2021-01-07

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Phenylephrine (2.5 mg) Witch Hazel (500 mg)

Inactive Ingredients

Aloe Vera Leaf Edetate Disodium Hydroxyethyl Cellulose (140 Mpa.s At 5%) Methylparaben Polysorbate 80 Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form Sulisobenzone .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH DRUG Active Since 2004-01-01

Description

Phenylephrine HCl 0.25% Witch hazel 50.0%

Purpose

Vasoconstrictor Astringent

Medication Information

Purpose

Vasoconstrictor Astringent

Description

Phenylephrine HCl 0.25% Witch hazel 50.0%

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

Purposes

Vasoconstrictor

Astringent

Warnings

For external use only

Directions

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

store at 15°C - 30°C (59°F - 89°F)

Active Ingredients

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Inactive Ingredients

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

Questions Or Comments?

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

When Using This Product

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

bleeding occurs
condition worsens or does not improve within 7 days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland

Principal Display Panel Tube Label

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 Carton Label

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)

Ask A Doctor Or Pharmacist Before Use If You Are

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

Structured Label Content

Uses (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

Purposes (PURPOSES)

Vasoconstrictor

Astringent

Warnings (WARNINGS)

For external use only

Directions (DIRECTIONS)

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 (OTHER INFORMATION)

store at 15°C - 30°C (59°F - 89°F)

Active Ingredients (ACTIVE INGREDIENTS)

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

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

When Using This Product (When using this product)

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 (Stop use and ask a doctor if)

bleeding occurs
condition worsens or does not improve within 7 days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center right away.

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

heart disease
high blood pressure
thyroid disease
diabetes
difficulty in urination due to enlargement of the prostate gland

Principal Display Panel Tube Label (PRINCIPAL DISPLAY PANEL - TUBE LABEL)

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 Carton Label (PRINCIPAL DISPLAY PANEL - CARTON LABEL)

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)

Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

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

Advanced Ingredient Data

[{"name": "ALOE VERA LEAF", "unii": "ZY81Z83H0X", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "EDETATE DISODIUM", "unii": "7FLD91C86K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "HYDROXYETHYL CELLULOSE (140 MPA.S AT 5%)", "unii": "8136Y38GY5", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "METHYLPARABEN", "unii": "A2I8C7HI9T", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "POLYSORBATE 80", "unii": "6OZP39ZG8H", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLENE GLYCOL", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PROPYLPARABEN", "unii": "Z8IX2SC1OH", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "WATER", "unii": "059QF0KO0R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SODIUM CITRATE, UNSPECIFIED FORM", "unii": "1Q73Q2JULR", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "SULISOBENZONE", "unii": "1W6L629B4K", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": ".ALPHA.-TOCOPHEROL ACETATE", "unii": "9E8X80D2L0", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "PHENYLEPHRINE", "unii": "1WS297W6MV", "classCode": "ACTIB", "strengthNumerator": "2.5", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}, {"name": "WITCH HAZEL", "unii": "101I4J0U34", "classCode": "ACTIB", "strengthNumerator": "500", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "g"}]

Raw Label Data

All Sections (JSON)

{"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", "PURPOSES": "Vasoconstrictor Astringent", "WARNINGS": "For external use only", "DIRECTIONS": "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": "store at 15°C - 30°C (59°F - 89°F)", "ACTIVE INGREDIENTS": "Phenylephrine HCl 0.25% Witch hazel 50.0%", "INACTIVE INGREDIENTS": "aloe barbadensis leaf juice, edetate disodium, hydroxyethyl cellulose, methylparaben, polysorbate 80, propylene glycol, propylparaben, purified water, sodium citrate, sulisobenzone, vitamin E ", "QUESTIONS OR COMMENTS?": "Call weekdays 8 AM to 5 PM EST at 1-724-733-7381", "When using this product": "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": "bleeding occurs condition worsens or does not improve within 7 days", "If pregnant or breast-feeding,": "ask a health professional before use.", "Keep out of reach of children.": "If swallowed, get medical help or contact a Poison Control Center right away.", "Ask a doctor before use if you have": "heart disease high blood pressure thyroid disease diabetes difficulty in urination due to enlargement of the prostate gland", "PRINCIPAL DISPLAY PANEL - TUBE LABEL": "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 - CARTON LABEL": "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)", "Ask a doctor or pharmacist before use if you are": "presently taking a prescription drug for high blood pressure or depression."}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.153579 · Updated: 2026-03-14T23:02:34.788055