Preparation H Medicated Wipes Cloth
FDA Label NDC 0573-0556

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 Medicated Wipes (NDC 0573-0556). 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 ingredient, purpose, uses, warnings, when using this product, stop use and ask a doctor if, if pregnant or breast-feeding,, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient

Witch hazel 50.0%

Purpose

Astringent

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • aids in protecting irritated anorectal areas

Warnings

For external use only

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

Stop Use And Ask A Doctor If

  • bleeding occurs
  • condition worsens or does not improve within 7 days

If Pregnant Or Breast-Feeding,

ask a health professional before use.

Keep Out Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

  • open the lid on the top of the wipes pouch
  • peel back wipes seal, remove completely and discard
  • grab the top wipe at the edge of the center fold and pull out of pouch
  • close lid after each use to retain moisture
  • adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area
  • use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
  • children under 12 years of age: consult a doctor

Other Information

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

Inactive Ingredients

aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Questions Or Comments?

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

Product Packaging

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

PREPARATION H Medicated Wipes

Hemorrhoidal Wipes with Witch Hazel

MAXIMUM STRENGTH FORMULA

Gentle, Everyday Cleansing To Reduce Irritation

48 Medicated Wipes With Aloe

Cools, Soothes and Comforts

Convenient, Easy to Use

For Hemorrhoidal and Vaginal Care

Flushable and Septic Safe

6 x 5 in. (15.2 x 12.7 cm)

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

Marketed By Wyeth Consumer Healthcare

Madison, NJ 07940 USA

Made in USA ©2009 Wyeth

10 Wipes Individually Wrapped

Each wipe is enclosed in a sealed foil pouch. Do not use if the pouch is broken or torn.

Other Uses

  • for vaginal care – cleanse the area by gently wiping, patting or blotting. Repeat as needed.
  • for use as a moist compress – if necessary, first cleanse the area as previously described. Fold new wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.

* Please review the disclaimer below.