Avedana Hemorrhoidal Cooling Gel
FDA Label NDC 43749-450

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Unipack Llc for the product Avedana Hemorrhoidal Cooling Gel (NDC 43749-450). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, uses, warnings, ask a doctor before use if you have, ask a doctor or pharmacist before use if you are, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredients

Phenylephrine HCl 0.25%

Witch hazel 50.0%

Purposes

Vasoconstrictor

Astringent

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

Warnings

For external use only

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

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

  • 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.

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)

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

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 (25.5 g Tube Label)

Principal Display Panel (25.5 g Tube 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)

Principal Display Panel (25.5 g Carton Label)

Principal Display Panel (25.5 g Carton Label)

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