SPL v8
SPL
SPL Set ID d6f6b482-d85d-001c-e053-2995a90ad98c
Route
TOPICAL
Published
Effective Date 2021-11-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Phenylephrine (25 mg) Witch Hazel (500 mg)
Inactive Ingredients
Propylene Glycol Sodium Citrate, Unspecified Form Methylparaben Edetate Disodium Propylparaben Sodium Metabisulfite Hydroxyethyl Cellulose (100 Mpa.s At 2%)

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-11-01
Description

Phenylephrine HCI, 0.25% Witch Hazel, 50.0%

Purpose

Vasoconstrictor Astringent

Medication Information

Purpose
  • Vasoconstrictor
  • Astringent
Description

Phenylephrine HCI, 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
Section 51945-4

Warnings

For external use only

Questions

www.drspharmacyusa.com

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
Active Ingredient
  • Phenylephrine HCI, 0.25%
  • Witch Hazel, 50.0%
Other Information

store at 20-25°C (68-77°F)

Inactive Ingredients

edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

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
If Pregnent 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.

Stop Using and Ask Your Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
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

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
Section 51945-4 (51945-4)

Purpose (PURPOSE)
  • Vasoconstrictor
  • Astringent
Warnings (WARNINGS)

For external use only

Questions (QUESTIONS)

www.drspharmacyusa.com

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
Active Ingredient (ACTIVE INGREDIENT)
  • Phenylephrine HCI, 0.25%
  • Witch Hazel, 50.0%
Other Information (OTHER INFORMATION)

store at 20-25°C (68-77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

edetate disodium, hydroxyethyl cellulose, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate, sodium metabisulphite

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
If Pregnent Or Breast Feeding (IF PREGNENT 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.

Stop Using and Ask Your Doctor If (STOP USING AND ASK YOUR DOCTOR IF)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
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
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

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:19.265650 · Updated: 2026-03-14T23:06:57.309434