Preparation H Rapid Relief Cloth
FDA Label NDC 0573-0554

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 0573-0554). 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 other, otc - purpose, 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.

Label Section Quick Index

Other

Drug Facts

Otc - Purpose

Active ingredientsPurposes
Glycerin 20%Protectant
Lidocaine 5%Local anesthetic
Phenylephrine HCl 0.25%Vasoconstrictor

Indications & Usage

Uses

  • for temporary relief of pain, soreness and burning
  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporarily reduces the swelling associated with irritated hemorrhoidal tissue
  • temporarily provides a coating for relief of anorectal discomforts
  • temporarily protects the inflamed, irritated anorectal surface to help make bowel movements less painful

Warnings

Warnings

For external use only

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

  • wash hands after use. Avoid contact with eyes
  • 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

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 with mild soap and warm water and rinse thoroughly. Gently dry by patting or blotting with a tissue or soft cloth before applying wipe.
  • apply externally to affected area up to 4 times daily.
  • unfold wipe and gently apply to the affected area by patting and then discard.
  • children under 12 years of age: ask a doctor

Storage And Handling

Other information

  • store at 20-25°C (68-77°F)
  • for best results, flush only one at a time

Inactive Ingredient

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, edetate disodium, propylene glycol, purified water, sodium benzoate

Otc - Questions

Questions or comments?

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

Principal Display Panel - 1 Wipe Pouch Label

TO OPEN: FOLD BACK ON DOTTED LINE. TEAR ON ARROW OR USE SCISSORS

PREPARATION H®

Child-Resistant Pouch

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL
WIPES

Totables®

LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN

  • Quickly numbs away pain
  • Soothes burning & itching on contact
  • Reduces swelling of inflamed tissue

    • 1 INDIVIDUALLY WRAPPED
    FLUSHABLE WIPE

    Not for
    individual sale

    6 x 4 in. (15.2 x 10.2 cm)

Principal Display Panel - 10 Wipe Pouch Carton

PREPARATION H®

New

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL WIPES

Totables®

LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN

Hygienically-wrapped
for personal use

  • Quickly numbs away pain
  • Soothes burning & itching
    on contact
  • Reduces swelling of
    inflamed tissue

    • 10
    Individually Wrapped
    FLUSHABLE WIPES

    6 x 4 in. (15.2 x 10.2 cm)

    Principal Display Panel (10 Wipe Pouch Carton)

    Principal Display Panel (10 Wipe Pouch Carton)

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