FDA.reportPublic FDA data

Medicated Wipes Hemorroidal Wipes With Witch Hazel

Manufacturer
FAMILY DOLLAR STORES
Effective date
2023-10-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:06:14

Label at a glance#

ProductMedicated Wipes Hemorroidal Wipes With Witch Hazel
Active ingredientWITCH HAZEL
Label structure8 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.  se up to 6 times daily or after each bowel movement and before...

Label contents#

Full prescribing information#

Active ingredients

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

  • rectal 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. 
  • se 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 wipe at a time
  • Close lid after every use to retain moisture
  • Discard after every use
  • store at room temperature 20 - 25° C (68 - 77° F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Water, DMDM Hydantoin, Glycerin, Benzalkonium Chloride, Citric Acid, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Extract

Questions?

OTC - QUESTIONS SECTION

1-800-639-3803Weekdays 9 AM to 4 PM EST

Package Labeling:

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Outer PackageOuter PackageInner PackageInner Package

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN2
844379witch hazel 500 MG/ML Medicated PadSCD2
844379witch hazel 50 % Medicated PadSY2
844379witch hazel 50 % Medicated WipesSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55319-402-00Medicated Wipes Hemorroidal Wipes With Witch Hazel48 in 1 BAGCLOTH482
55319-402-00Medicated Wipes Hemorroidal Wipes With Witch Hazel1.4717 mL in 1 PATCHCLOTH1.47172

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
55319-402MEDICATED WIPES HEMORROIDAL WIPES WITH WITCH HAZEL (WITCH HAZEL) CLOTH [FAMILY DOLLAR STORES]22 package rows20240101_7c224f3b-a9eb-4e2a-9237-2823fefd98d6.zip

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55319-40255319-402-00

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
DMDM HYDANTOINBYR0546TOWIACT
GLYCERINPDC6A3C0OXIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
COCAMIDOPROPYL BETAINE5OCF3O11KXIACT
ALOE VERA LEAFZY81Z83H0XIACT
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
5a18763d-7006-f680-e063-6394a90a6cf37c224f3b-a9eb-4e2a-9237-2823fefd98d62026-08-28WarningsExact identifier
spl set id: 7c224f3b-a9eb-4e2a-9237-2823fefd98d6

Reported adverse events (FAERS/openFDA)#

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