FDA.reportPublic FDA data

PREPARATION H MEDICATED WIPES

Manufacturer
Haleon US Holdings LLC
Effective date
2024-03-02
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:09:19

Label at a glance#

ProductPREPARATION H MEDICATED WIPES
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

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 ...

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch hazel 50%

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

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

  • 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

SPL UNCLASSIFIED SECTION

  • for best results, flush only one or two wipes at a time

store at 20-25°C (68-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, anhydrous citric acid, cocamidopropyl betaine, cocamidopropyl dimethylamine, diazolidinyl urea, dichloroacetic, dimethylaminopropylamine, glycerin, methylparaben, monochloroacetic acid, potassium sorbate, propylene glycol, sodium benzoate, sodium chloride, sodium citrate, sodium glycolate, water

Questions or comments?

OTC - QUESTIONS SECTION

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

Additional information

SPL UNCLASSIFIED SECTION

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.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK

©2022 GSK or licensor

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PREPARATIONH

Medicated Wipes

HEMORRHOIDAL WIPES

WITH WITCH HAZEL

gentle, everyday cleansing to reduce irritation

FLUSHABLE & SEPTIC SAFE

  • Cools, Soothes and Comforts
  • Convenient, Easy to Use
  • For Hemorrhoidal and Vaginal Care

WITH ALOE

3 60 COUNT POUCHES

180 MEDICATED WIPES

6 x 5 in. (15.2 x 12.7 cm)

000077729 Front Carton

PreparationH Medicated Wipes 180 ct
PreparationH Medicated Wipes 180 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN3
844379witch hazel 500 MG/ML Medicated PadSCD3
844379witch hazel 50 % Medicated PadSY3
844379witch hazel 50 % Medicated WipesSY3

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
ce6d5c06-3ae0-18a6-d5b3-8cd3cc0f8906Product name720210625
f52be47f-7aa7-46c0-b1fa-50c18dd50206Product name120201029
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0573-0557-01PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH483
0573-0557-02PREPARATION H MEDICATED WIPES2 in 1 CARTONCLOTH23
0573-0557-02PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH483
0573-0557-03PREPARATION H MEDICATED WIPES60 in 1 POUCHCLOTH603
0573-0557-03PREPARATION H MEDICATED WIPES3 in 1 CARTONCLOTH33
0573-0557-04PREPARATION H MEDICATED WIPES4 in 1 CARTONCLOTH43
0573-0557-04PREPARATION H MEDICATED WIPES48 in 1 POUCHCLOTH483

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0573-0557PREPARATION H MEDICATED WIPES (WITCH HAZEL) CLOTH [HALEON US HOLDINGS LLC]3Current NDC, Legacy NDC, 7 package rows20240303_3b1cfa8a-942f-471e-b7c0-744f83b687a0.zip

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0573-05570573-0557-01, 0573-0557-02, 0573-0557-03, 0573-0557-04

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 18 matching rows.

Name, UNII, Kind table
NameUNIIKind
ALOE VERA LEAFZY81Z83H0XIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
COCAMIDOPROPYL DIMETHYLAMINEL36BM7DG2TIACT
DIAZOLIDINYL UREAH5RIZ3MPW4IACT
DICHLOROACETIC ACID9LSH52S3LQIACT
3-DIMETHYLAMINOPROPYLAMINEI98I2UEC03IACT
GLYCERINPDC6A3C0OXIACT
METHYLPARABENA2I8C7HI9TIACT
CHLOROACETIC ACID5GD84Y125GIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM CHLORIDE451W47IQ8XIACT
SODIUM CITRATE, UNSPECIFIED FORM1Q73Q2JULRIACT
SODIUM GLYCOLATEB75E535IMIIACT
WATER059QF0KO0RIACT
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
PREPARATION H MEDICATED WIPESWITCH HAZELHaleon US Holdings LLC3b1cfa8a-942f-471e-b7c0-744f83b687a02024-03-02WarningsExact identifier
ndc (package): 0573-0557-01
ndc (package): 0573-0557-03
ndc (package): 0573-0557-04
ndc (package): 0573-0557-02
ndc (product): 0573-0557
ndc11 (package): 00573055702
ndc11 (package): 00573055701
ndc11 (package): 00573055703
ndc11 (package): 00573055704
spl id: 12ae39cf-be29-3d34-e063-6394a90a3cc6
spl set id: 3b1cfa8a-942f-471e-b7c0-744f83b687a0

Reported adverse events (FAERS/openFDA)#

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