Preparation H Rapid Relief Spray
FDA Label NDC 0573-2890

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Haleon Us Holdings Llc for the product Preparation H Rapid Relief (NDC 0573-2890). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding active ingredients, purposes, indications & usage, warnings, ask a doctor before use if you have, otc - ask doctor/pharmacist, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Active Ingredients

Lidocaine 5%

Phenylephrine HCl 0.25%

Purposes

Local anesthetic

Vasoconstrictor

Indications & 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

Warnings

Warnings

For external use only

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

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

Otc - Ask Doctor/Pharmacist

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

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

Otc - Pregnancy Or Breast Feeding

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

Otc - 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.

Dosage & 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

Storage And Handling

Other information

  • Store at 20-25°C (68-77°F)

Inactive Ingredient

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

Otc - Questions

Questions or comments?

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

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

    Preph Relief Spray With Lidocaine 3.8 Oz(107.7 G) (Image 01)

    Preph Relief Spray With Lidocaine 3.8 Oz(107.7 G) (Image 01)

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