3dc07e6b-803d-1c11-e054-00144ff88e88

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

Purpose

Vasoconstrictor Astringent

Description

Phenylephrine HCI, 0.25%


Medication Information

Warnings

For external use only

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
  • Vasoconstrictor
  • Astringent
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 20-25°C (68-77°F)

Inactive Ingredients

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

Description

Phenylephrine HCI, 0.25%

Questions

ohiolabpharma.us

Package Label

COOLING RELIEF

OLP HEMORRHOIDAL COOLING GEL

Active Ingredient

Phenylephrine HCI, 0.25%

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

Warnings (WARNINGS)

For external use only

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
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 20-25°C (68-77°F)

Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions (QUESTIONS)

ohiolabpharma.us

Package Label (PACKAGE LABEL)

COOLING RELIEF

OLP HEMORRHOIDAL COOLING GEL

Active Ingredient (ACTIVE INGREDIENT)

Phenylephrine HCI, 0.25%

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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