FDA.reportPublic FDA data

Preparation H

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-02
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:10:29

Label at a glance#

ProductPreparation H Soothing Relief Cooling
Active ingredientWITCH HAZEL
Label structure10 sections

Indications and uses

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

Dosage and administration

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 applying the spray. apply externally to the affected area up to 6 times daily or after each bowel movement children under 12 years of age: consult a doctor shake well before using hold 3 to 6” away from rectal area, spray to moisten ...

Label contents#

Full prescribing information#

Active ingredients

OTC - ACTIVE INGREDIENT SECTION

Witch hazel 20%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

For external use only

When using this product

OTC - WHEN USING SECTION

  • 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.
  • 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

OTC - STOP USE SECTION

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

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 applying the spray.
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • children under 12 years of age: consult a doctor
  • shake well before using
  • hold 3 to 6” away from rectal area, spray to moisten and then wipe off excess, if desired

Other information

SPL UNCLASSIFIED SECTION

  • store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, dehydroxanthan gum, edetate disodium, glycerin, isobutane, propylene glycol, purified water, sodium benzoate, sodium citrate

Questions?

OTC - QUESTIONS SECTION

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

Additional information

SPL UNCLASSIFIED SECTION

No Touch Spray

Do not use if sleeve band around cap is broken or missing

Dist. By: GSK Consumer Healthcare

Warren, NJ 07059

Trademarks owned or licensed by GSK

©2021 GSK or licensor

PAA172637 (Front Carton)

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0573-2889-01

PREPARATION H

NEW!

soothing
RELIEF
cooling spray

HEMORRHOIDAL SPRAY

with ALOE

Quickly Soothes and Cools Discomfort

Relieves Itching, Burning and Irritation

Gentle for Daily Use

NET WT 2.7 OZ (77 g)

Prep H Soothing Relief Cooling Spray 2.7oz (77 g)
Prep H Soothing Relief Cooling Spray 2.7oz (77 g)

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-28890573-2889-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
BENZYL ALCOHOLLKG8494WBHIACT
DEHYDROXANTHAN GUM63ZP7I1BQOIACT
EDETATE DISODIUM7FLD91C86KIACT
GLYCERINPDC6A3C0OXIACT
ISOBUTANEBXR49TP611IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
WITCH HAZEL101I4J0U34ACTIB

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3417cff4-f8e5-327e-e063-6394a90ad70a35b4e678-b9e7-4fca-a99d-8f9f77e66e122025-05-01WarningsExact identifier
spl set id: 35b4e678-b9e7-4fca-a99d-8f9f77e66e12

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.