Preparation H Rapid Relief Cream
FDA Label NDC 0573-2843

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 0573-2843). 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, otc - ask doctor, otc - ask doctor/pharmacist, otc - when using, otc - stop use, 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 14.4%Protectant
Lidocaine 5%Local anesthetic
Phenylephrine HCl 0.25%Vasoconstrictor
White petrolatum 15%Protectant

Indications & Usage

Uses

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

Otc - Ask Doctor

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.

Otc - When Using

When using this product

  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put into the rectum by using fingers or any mechanical device or applicator

Otc - Stop Use

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 wipe. Gently dry by patting or blotting with a tissue or a soft cloth before applying this cream.
  • 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

Storage And Handling

Other information

store at 20-25°C (68-77°F)

Inactive Ingredient

Inactive ingredients

aloe barbadensis leaf extract, anhydrous citric acid, butylated hydroxyanisole, carboxymethylcellulose sodium, cetyl alcohol, citric acid monohydrate, dexpanthenol, edetate disodium, glyceryl monostearate, methylparaben, mineral oil, polyoxyl lauryl ether, polyoxyl stearyl ether, propyl gallate, propylene glycol, propylparaben, purified water, sodium benzoate, stearyl alcohol, tocopherols excipient, vitamin E acetate, xanthan gum

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 - 23 G Tube Label

To open: push down on cap while turning counterclockwise.

Child-Resistant Cap

PREPARATION H®

HEMORRHOIDAL CREAM

RAPID RELIEF
WITH LIDOCAINE

  • Rapid numbing relief of pain, itching & burning
  • Reduces swelling & provides a soothing
    protective layer

    • NET WT 0.75 OZ (23g)

Principal Display Panel - 23 G Tube Carton

PREPARATION H®

New Benefit
Now Reduces Swelling
See new label

RAPID RELIEF
WITH
LIDOCAINE

HEMORRHOIDAL
CREAM

LIDOCAINE
PHENYLEPHRINE HCl
GLYCERIN
WHITE PETROLATUM

5%
HIGHEST STRENGTH
LIDOCAINE
AVAILABLE

  • Rapid numbing relief of pain,
    itching & burning
  • Reduces swelling & provides
    a soothing protective layer

    • 1 TUBE | NET WT 0.75 OZ (23 g)

* Please review the disclaimer below.