Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 27db1d58-4609-4a80-af2f-9e36f10482e1
Route
TOPICAL
Published
Effective Date 2021-11-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Lidocaine (50 mg) Phenylephrine (2.5 mg)
Inactive Ingredients
Aloe Vera Leaf Anhydrous Citric Acid Edetate Disodium Glycerin Isobutane Malic Acid Menthol, Unspecified Form Propyl Gallate Propylene Glycol Alcohol Sodium Benzoate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-02-01
Description

Lidocaine 5% Phenylephrine HCl 0.25%

Purpose

Local anesthetic Vasoconstrictor

Medication Information

Warnings and Precautions

Warnings

For external use only

Flammable:Do not use while smoking or near heat or flame

Indications and Usage

Uses

  • Helps relieve the local discomfort and itching associated with hemorrhoids
  • For the temporary relief of pain, soreness or burning
  • Temporarily reduces the swelling associated with irritation in hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue
Purpose

Local anesthetic Vasoconstrictor

Dosage and Administration

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • Shake well before using
  • Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
  • Apply externally to the affected area up to 4 times daily
  • Children under 12 years of age: consult a doctor
Description

Lidocaine 5% Phenylephrine HCl 0.25%

Section 44425-7

Other information

  • Store at 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50568-5

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 51727-6

Inactive ingredients

aloe barbadensis leaf juice, citric acid, disodium EDTA, glycerin, isobutane, malic acid, menthol, propyl gallate, propylene glycol, SD alcohol 40-B, sodium benzoate, water

Section 53413-1

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

Section 53414-9

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Local anesthetic

Vasoconstrictor

Active Ingredients

Lidocaine 5%

Phenylephrine HCl 0.25%

Additional Information

No-Touch Spray

Do not use if clear safety seal around cap is broken or missing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

@2021 GSK or licensor

For most recent product information, visit www.preparationh.com

Principal Display Panel

NEW!

PREPARATIONH

RAPID RELIEF

WITH

LIDOCAINE

HEMORRHOIDAL SPRAY

LIDOCAINE

PHENYLEPHRINE HCl

  • Rapid numbing relief of pain,

    itching and burning

  • Reduces swelling of

    inflamed tissue
  • Highest strength lidocaine

    available

NET WT 3.8 OZ (107.7 g)

000070918 Front Label

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
  • Warning -avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
  • Warning -use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
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

Structured Label Content

Indications and Usage (34067-9)

Uses

  • Helps relieve the local discomfort and itching associated with hemorrhoids
  • For the temporary relief of pain, soreness or burning
  • Temporarily reduces the swelling associated with irritation in hemorrhoids
  • Temporarily shrinks hemorrhoidal tissue
Dosage and Administration (34068-7)

Directions

  • Adults: when practical, cleanse the affected area by patting or blotting with an appropriate cleansing pad
  • Gently dry by patting or blotting with toilet tissue or a soft cloth before application of this product
  • Shake well before using
  • Hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired
  • Apply externally to the affected area up to 4 times daily
  • Children under 12 years of age: consult a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Flammable:Do not use while smoking or near heat or flame

Section 44425-7 (44425-7)

Other information

  • Store at 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you arepresently taking a prescription drug for high blood pressure or depression.

Section 51727-6 (51727-6)

Inactive ingredients

aloe barbadensis leaf juice, citric acid, disodium EDTA, glycerin, isobutane, malic acid, menthol, propyl gallate, propylene glycol, SD alcohol 40-B, sodium benzoate, water

Section 53413-1 (53413-1)

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374

Section 53414-9 (53414-9)

If pregnant or breast-feeding,ask a health professional before use.

Purposes

Local anesthetic

Vasoconstrictor

Active Ingredients (Active ingredients)

Lidocaine 5%

Phenylephrine HCl 0.25%

Additional Information

No-Touch Spray

Do not use if clear safety seal around cap is broken or missing

Distributed by:

GSK Consumer Healthcare

Warren, NJ 07059

Trademarks are owned by or licensed to the GSK group of companies.

@2021 GSK or licensor

For most recent product information, visit www.preparationh.com

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NEW!

PREPARATIONH

RAPID RELIEF

WITH

LIDOCAINE

HEMORRHOIDAL SPRAY

LIDOCAINE

PHENYLEPHRINE HCl

  • Rapid numbing relief of pain,

    itching and burning

  • Reduces swelling of

    inflamed tissue
  • Highest strength lidocaine

    available

NET WT 3.8 OZ (107.7 g)

000070918 Front Label

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
  • Warning -avoid spraying in eyes. Contents under pressure. Do not puncture or incinerate. Do not store at temperature above 120°F. Keep out of reach of children.
  • Warning -use only as directed. Intentional misuse by deliberately concentrating and inhaling the contents can be harmful or fatal.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • bleeding occurs
  • condition worsens or does not improve within 7 days
  • an allergic reaction develops
  • the symptom being treated does not subside or if redness, irritation, swelling, pain, or other symptoms develop or increase
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

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:49.762711 · Updated: 2026-03-14T23:02:34.788055