SPL v4
SPL
SPL Set ID 3dc07e6b-803d-1c11-e054-00144ff88e88
Route
TOPICAL
Published
Effective Date 2016-10-15
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 FINAL Active Since 2017-02-01

Description

Phenylephrine HCI, 0.25%

Purpose

Vasoconstrictor Astringent


Medication Information

Purpose
  • Vasoconstrictor
  • Astringent
Description

Phenylephrine HCI, 0.25%

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

Questions

ohiolabpharma.us

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
Package Label

COOLING RELIEF

OLP HEMORRHOIDAL COOLING GEL

Active Ingredient

Phenylephrine HCI, 0.25%

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

For external use only

Questions (QUESTIONS)

ohiolabpharma.us

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
Package Label (PACKAGE LABEL)

COOLING RELIEF

OLP HEMORRHOIDAL COOLING GEL

Active Ingredient (ACTIVE INGREDIENT)

Phenylephrine HCI, 0.25%

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

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