Dr Butler Hemorrhoid & Fissure Ointment Pf

Dr Butler Hemorrhoid & Fissure Ointment Pf
SPL v5
SPL
SPL Set ID f526199e-5c9e-7a3c-e053-2a95a90aa98e
Route
TOPICAL
Published
Effective Date 2025-07-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (4 g) Phenylephrine (0.25 g)
Inactive Ingredients
Horse Chestnut Aloe Ascorbic Acid Calendula Officinalis Flower Caprylhydroxamic Acid Centella Asiatica Cholecalciferol Sunflower Oil Hydrocortisone Lysine Hydrochloride Mineral Oil Caprylic/capric Triglyceride Olive Oil Asian Ginseng Matricaria Chamomilla Flowering Top Oil Petrolatum Propylene Glycol Punica Granatum Root Bark Glyceryl Caprylate Vitamin A Palmitate Laminaria Digitata Hyaluronate Sodium Porphyra Umbilicalis Stearic Acid .alpha.-tocopherol Acetate Triethoxycaprylylsilane Water Glycerin Zinc Oxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2023-02-20

Description

Lidocaine USP 4% Phenylephrine HCl 0.25%

Purpose

Analgesic (pain relief) Vasoconstrictor


Medication Information

Purpose

Analgesic (pain relief)

Vasoconstrictor

Description

Lidocaine USP 4% Phenylephrine HCl 0.25%

Uses
  • temporarily shrinks hemorrhoidal tissue
  • for the temporary relief of pain, soreness, or burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
Warnings

For external use only including the skin of the anal canal.

Directions
  • children under 12 years of age consult your pediatrician.
  • adults: apply to affected area up to 4 times daily.
  • cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.
  • to use dispensing cap, attach it to tube, lubricate well, then apply externally to the skin of the anal canal only. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly
Other Information
  • store at 15º-30º C (59º-86º F)
Active Ingredients

Lidocaine USP 4%

Phenylephrine HCl 0.25%

0.75oz / 21.3g Tube

Inactive Ingedients

Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, olea europaea (olive) fruit oil, panax ginseng root extract, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, retinyl palmitate, sodium hyaluronate, stearic acid, tocopheryl acetate, triethoxycaprylysilane, water, zinc oxide

When Using This Product
  • do not exceed recommended dosage unless directed by a doctor
  • when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum
Stop Use and Ask A Doctor If
  • condition worsens or does not improve within seven (7) days
  • bleeding occurs
  • an allergic reation develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If Pregnant Or Breast Feeding

as a health care professional before use.

Keep Out of Reach of Children

if swallowed, seek medical help or contact a Poison Control Center right away.

Carton of 12 0.07oz / 2g Packets

Ask A Doctor Before Use If You Have
  • allergies to any of the components of this product
  • difficulty in urination due to enlargement of the prostate gland
  • Diabetes
  • Heart Disease
  • High Blood Pressure
  • Thyroid Disease
  • presently taking a prescription for high blood pressure or depression

Structured Label Content

Uses
  • temporarily shrinks hemorrhoidal tissue
  • for the temporary relief of pain, soreness, or burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
Purpose

Analgesic (pain relief)

Vasoconstrictor

Warnings

For external use only including the skin of the anal canal.

Directions
  • children under 12 years of age consult your pediatrician.
  • adults: apply to affected area up to 4 times daily.
  • cleanse the affected area with mild soap and warm water, rinse thoroughly, and then gently dry (patting or blotting) with tissue or soft cloth before use.
  • to use dispensing cap, attach it to tube, lubricate well, then apply externally to the skin of the anal canal only. Thoroughly cleanse dispensing cap after use with mild soap and warm water and rinse thoroughly
Other Information
  • store at 15º-30º C (59º-86º F)
Active Ingredients

Lidocaine USP 4%

Phenylephrine HCl 0.25%

0.75oz / 21.3g Tube (0.75oz / 21.3g tube)

Inactive Ingedients

Aesculus hippocastanum (horse chestnut) extract, aloe barbadensis leaf extract, ascorbic acid, calendula officinalis flower extract, caprylhydroxamic acid, caprylic/capric triglyceride, centella asiatica extract, chamomile recutita (matricaria) flower extract, cholecalciferol, glycerin, glyceryl caprylate, helianthus annuus (sunflower) seed oil, hydrocortisone, laminaria digitata (algae) extract, lysine HCl, mineral oil, olea europaea (olive) fruit oil, panax ginseng root extract, petrolatum, porphyria umbilicalis extract, propylene glycol, punica granatum fruit extract, retinyl palmitate, sodium hyaluronate, stearic acid, tocopheryl acetate, triethoxycaprylysilane, water, zinc oxide

When Using This Product (When using this product)
  • do not exceed recommended dosage unless directed by a doctor
  • when using finger cots or an applicator, apply externally or to the skin of the anal canal only. Do not put this product into the rectum
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve within seven (7) days
  • bleeding occurs
  • an allergic reation develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain or other symptoms develop or increase
If Pregnant Or Breast Feeding (If pregnant or breast-feeding)

as a health care professional before use.

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

if swallowed, seek medical help or contact a Poison Control Center right away.

Carton of 12 0.07oz / 2g Packets (Carton of 12 0.07oz / 2g packets)

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • allergies to any of the components of this product
  • difficulty in urination due to enlargement of the prostate gland
  • Diabetes
  • Heart Disease
  • High Blood Pressure
  • Thyroid Disease
  • presently taking a prescription for high blood pressure or depression

Advanced Ingredient Data


Raw Label Data

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