FDA.reportPublic FDA data

Dr Butlers Hemorrhoid

Manufacturer
Beyond Health, PA
Effective date
2025-07-23
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 01:08:26

Label at a glance#

ProductDr Butlers Hemorrhoid
Active ingredientWITCH HAZEL
Label structure8 sections

Indications and uses

Helps relieve the local itching and discomfort associated with hemorrhoids Temporay relief of irritation and burning Aids in protecting irritated anorectal areas

Dosage and administration

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 additional 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 Ingredieni

OTC - ACTIVE INGREDIENT SECTION

Organic Witch Hazel 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

  • Helps relieve the local itching and discomfort associated with hemorrhoids
  • Temporay 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 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. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 additional 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.

Othet Information

SPL UNCLASSIFIED SECTION

  • store at room temperature 20-25ºC (68-77ºF)
  • for use as moist compress - first cleanse the area as previously described. Fold wipe to desired size and place in contact with skin tissue. Leave in place for 15 minutes and repeat as needed.

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Purified Water

Tocopherol

Rosmarinus Officinalis (Rosemary) Leaf Extract

Lysine

Calendula Officinalis Flower Extract

Chamomilla Recutita (Matricaria) Flower Extract

Sodium Citrate

Betaine

Caprylhydroxamic Acid

Glyceryl Caprylate

Glycerin

48 count package

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PDPPDP

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
844379witch hazel 50 % Medicated PadPSN1
844379witch hazel 500 MG/ML Medicated PadSCD1
844379witch hazel 50 % Medicated PadSY1
844379witch hazel 50 % Medicated WipesSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
d1c9d1af-bddd-448d-86f7-69052b7d5b47Product name120220627
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70942-100-00Dr Butlers Hemorrhoid3 g in 1 PACKAGESWAB31
70942-100-48Dr Butlers Hemorrhoid48 in 1 CONTAINERSWAB481

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
70942-10070942-100-00, 70942-100-48

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
ROSEMARYIJ67X351P9IACT
CHAMOMILEFGL3685T2XIACT
LYSINEK3Z4F929H6IACT
WATER059QF0KO0RIACT
GLYCERYL CAPRYLATETM2TZD4G4AIACT
SODIUM CITRATE1Q73Q2JULRIACT
BETAINE3SCV180C9WIACT
WITCH HAZEL101I4J0U34ACTIB
CALENDULA OFFICINALIS FLOWERP0M7O4Y7YDIACT
CAPRYLHYDROXAMIC ACIDUPY805K99WIACT
GLYCERINPDC6A3C0OXIACT

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
Dr Butlers HemorrhoidWITCH HAZEL 50%Beyond Health, PA3a9fea0c-b189-c77e-e063-6294a90a05832025-07-23WarningsExact identifier
ndc (package): 70942-100-48
ndc (package): 70942-100-00
ndc (product): 70942-100
ndc11 (package): 70942010048
ndc11 (package): 70942010000
spl id: 3a9fea0c-b18a-c77e-e063-6294a90a0583
spl set id: 3a9fea0c-b189-c77e-e063-6294a90a0583

Reported adverse events (FAERS/openFDA)#

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