FDA.reportPublic FDA data

Medicated Hemorrhoidal Pads

Manufacturer
Cardinal Health
Effective date
2025-12-05
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:20:12

Label at a glance#

ProductMedicated Hemorrhoidal Pads
Active ingredientWITCH HAZEL
Label structure9 sections

Indications and uses

provides temporary relief of local itching and discomfort associated with hemorrhoids temporary relief of irritation and burning. aids in protecting irritated anorectal areas.

Dosage and administration

adults: cleane the affected area with mild soap and warm water, and rinse thoroughly gently dry by patting or blotting with toilet tissue prior to applying. apply externally to the affected area up to 6 times daily or after each bowel movement dispose of pad in thrash after use and wash hands, do not flush children under 12 years of age: consult a doctor

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch hazel 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

  • provides temporary relief of 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 use more than directed unless told to do so by a doctor
  • do not put directly in 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 Poison Control Center right away. (1-800-222-1222).

Directions

DOSAGE & ADMINISTRATION SECTION

adults:

  • cleane the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue prior to applying.
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • dispose of pad in thrash after use and wash hands, do not flush

children under 12 years of age: consult a doctor

Other Information

SPL UNCLASSIFIED SECTION

  • store at room temperature 15- 30 oC (59 - 86 oF)
  • for use as a moist compress - if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use.

Inactive ingredients

INACTIVE INGREDIENT SECTION

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

Questions or Comments?

OTC - QUESTIONS SECTION

(800) 320-6603

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER TM

NDC 70000-0364-1

Medicated Hemorrhoidal Pads

WITCH HAZEL, 50% | Astringent

Provides Immediate Relief from Itching and Burning Caused by Hemorrhoids

Witch Hazel to Soothe and Protect Irritated Areas

COMPARE TO TUCKS® MEDICATED COOLING PADS active ingredient*

100% Money Back Guarantee

100 PADS

*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark Tucks® Medicated Cooling Pads.

LabelLabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN8
844379witch hazel 500 MG/ML Medicated PadSCD8
844379witch hazel 50 % Medicated PadSY8
844379witch hazel 50 % Medicated WipesSY8

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
7792dadb-52b6-46b6-8fdf-80b1171065b5Product name120180810
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70000-0364-12021-03-10C16284748780-1ba0f9c33-2bc0-a910-e053-dadaa90a0b85Drug Facts

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0364-1Medicated Hemorrhoidal Pads100 in 1 JARCLOTH1008
70000-0364-1Medicated Hemorrhoidal Pads1 in 1 CARTONCLOTH18

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0364-1EA - Each70000-036440a7d4fd-f676-4c3d-87e0-24f4fef8551e12019-08-06

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
70000-036470000-0364-1

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
WATER059QF0KO0RIACT
ALCOHOL3K9958V90MIACT
GLYCERINPDC6A3C0OXIACT
PHENOXYETHANOLHIE492ZZ3TIACT
ALOEV5VD430YW9IACT
DECYL GLUCOSIDEZ17H97EA6YIACT
POTASSIUM SORBATE1VPU26JZZ4IACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SODIUM BENZOATEOJ245FE5EUIACT
CITRIC ACID MONOHYDRATE2968PHW8QPIACT
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
Medicated Hemorrhoidal PadsWITCH HAZELCardinal Health0b49db40-7abc-4e62-b6da-4b9f5b0ae16d2025-12-05WarningsExact identifier
ndc (package): 70000-0364-1
ndc (product): 70000-0364
ndc11 (package): 70000036401
spl id: 4539d93f-d5be-fdbe-e063-6294a90a8c51
spl set id: 0b49db40-7abc-4e62-b6da-4b9f5b0ae16d

Reported adverse events (FAERS/openFDA)#

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