FDA.reportPublic FDA data

Witch Hazel

Manufacturer
Giant Eagle
Effective date
2023-01-10
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 23:53:06

Label at a glance#

ProductWitch 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

Adult: 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 hemorrhoidal treatments, and then discard. Children under 12 years of age: consult a doctor. Flush or dispose of wipe in trash. *For best results, flush no more than one wipe at a time.

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 recommendeed 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 the reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact Poison Control Center right away (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

  • Adult: 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 hemorrhoidal treatments, and then discard.
  • Children under 12 years of age: consult a doctor.
  • Flush or dispose of wipe in trash.
  • *For best results, flush no more than one wipe at a time.

Other information

OTHER SAFETY INFORMATION

  • Store at room temperature 20 - 25°C (68 - 77°F).
  • For vaginal care - cleanse the area by gently wiping, patting, or blotting. Repeat as needed.
  • For use as moist compress - if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for 15 minutes and repeat as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Alcohol, Aloe, Citric Acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

giant eagle

MEDICATED

HEMORRHOIDAL WIPES

COMPARE TO PREPARATION H MEDICATED WIPES

COOLS • SOOTHES • COMFORTS • CONVENIENT • EASY TO USE

FLUSHABLE MILD EVERYDAY WIPES with witch hazel and aloe

48 WIPES • 6 in x 5 in (15.2cm x 12.7cm)

boxbox

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
56194-500-012025-01-30C16284748780-12cef2736-748f-d83d-e063-dadaa90ab31fMedicated Hemorrhoidal Wipes

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
56194-500-01Witch Hazel48 in 1 POUCHCLOTH482

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
56194-500WITCH HAZEL (MEDICATED HEMORRHOIDAL WIPES) CLOTH [GIANT EAGLE]2Legacy NDC, 1 package rows20230111_cdc87b48-ec7c-958b-e053-2a95a90a8c9b.zip

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
56194-50056194-500-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
POTASSIUM SORBATE1VPU26JZZ4IACT
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
SODIUM BENZOATEOJ245FE5EUIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
ALOEV5VD430YW9IACT
ALCOHOL3K9958V90MIACT
DECYL GLUCOSIDEZ17H97EA6YIACT
PHENOXYETHANOLHIE492ZZ3TIACT
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
f1eb10de-7b12-cac4-e053-2995a90a6d8ecdc87b48-ec7c-958b-e053-2a95a90a8c9b2023-01-10WarningsExact identifier
spl id: f1eb10de-7b12-cac4-e053-2995a90a6d8e
spl set id: cdc87b48-ec7c-958b-e053-2a95a90a8c9b

Reported adverse events (FAERS/openFDA)#

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