FDA.reportPublic FDA data

REXALL 4CA81001

Manufacturer
Old East Main Co. | Nice-Pak Products, LLC
Effective date
2026-09-03
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
daily-update
Hydrated at
2026-09-08 02:02:35

Label at a glance#

ProductRexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazel
Active ingredientWITCH HAZEL
Label structure12 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 lid and peel back label on top of the wipes pouch Pull out wipe and close lid or reseal label 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

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 lid and peel back label on top of the wipes pouch
  • Pull out wipe and close lid or reseal label
  • 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

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Water, Glycerin, Propylene Glycol, Aloe Barbadensis Leaf Juice, Ciric Acid, Disodium Cocoamphodiacetate, Iodopropynyl Butylcarbamate, PEG-75 Lanolin, Sodium Citrate, 2-Bomo-2-Nitropropane-1,3-Diol

Claims

SPL UNCLASSIFIED SECTION

Made with Advanced Flushable Technology  from plant-based fibers so they're safe for well-maintained sewers and septics. Not recommended for use with basement pump systems. 

Flush only one wipe at a time.

Adverse Reaction

ADVERSE REACTIONS SECTION

DISTRIBUTED BY OLD EAST MAIN CO.

100 MISSION RIDGE, GOODLETTSVILLE, TN 37072 USA

Since 1903 Rexall  ®is a registered trademark of Rexall Sundown, Inc.

©2022 Advanced Flushable Technology  is a registered trademark of Nice-Pak Product, Inc. Made in USA of domestic and imported materials.

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Since 1903

Rexall  ®

Flushable Medicated Wipes

Hemorrhoidal wipes with witch hazel

Enriched with Aloe

Since 1903 Rexall  ®is a registered trademark of Rexall Sundown, Inc.

48 Medicated Wipes

5 in X 6 in (12.7 cm X 15.2 cm)

image descriptionimage description

image descriptionimage description

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 Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
WITCH HAZELACTIVE INGREDIENT101I4J0U342
WITCH HAZELACTIVE MOIETY101I4J0U342
ALOE ARBORESCENS LEAFINACTIVE INGREDIENT09TD8L5SQV2
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL2
BRONOPOLINACTIVE INGREDIENT6PU1E16C9W2
DISODIUM COCOAMPHODIACETATEINACTIVE INGREDIENT18L9G3U51M2
GLYCERININACTIVE INGREDIENTPDC6A3C0OX2
IODOPROPYNYL BUTYLCARBAMATEINACTIVE INGREDIENT603P14DHEB2
PEG-75 LANOLININACTIVE INGREDIENT09179OX7TB2
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V32
SODIUM CITRATEINACTIVE INGREDIENT1Q73Q2JULR2
WATERINACTIVE INGREDIENT059QF0KO0R2

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
55910-10555910-105-48

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
WITCH HAZEL101I4J0U34ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
IODOPROPYNYL BUTYLCARBAMATE603P14DHEBIACT
DISODIUM COCOAMPHODIACETATE18L9G3U51MIACT
BRONOPOL6PU1E16C9WIACT
ALOE ARBORESCENS LEAF09TD8L5SQVIACT
SODIUM CITRATE1Q73Q2JULRIACT
PEG-75 LANOLIN09179OX7TBIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
72024-11-07full-release2026-06-01 00:35:20

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 14 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBEMULSION / TOPICAL1.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii+route
2 equally ranked IID candidates
DISODIUM COCOAMPHODIACETATEDISODIUM COCOAMPHODIACETATE18L9G3U51MSHAMPOO, SUSPENSION / TOPICAL5 %w/vExact identifier — unii+route
2 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBSOLUTION / TOPICAL1 %w/wExact identifier — unii+route
6 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLCLOTH / TOPICAL4.2 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBAEROSOL / TOPICAL1.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXCLOTH / TOPICAL0.05 mg/mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBAEROSOL / TOPICAL1.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PEG-75 LANOLINPEG-75 LANOLIN09179OX7TBEMULSION / TOPICAL1.5 %w/wExact identifier — unii+route
6 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3CLOTH / TOPICAL0.03 mg/mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates

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
Rexall Medicated WipesHemorrhoidal wipe Hemorrhoidal wipes with witch hazelWITCH HAZELOld East Main Co.2055289d-962e-46a9-b371-b5bb93dd46b42026-09-03Warnings, Adverse reactionsExact identifier
ndc (package): 55910-105-48
ndc (product): 55910-105
ndc11 (package): 55910010548
spl id: 5a984728-97bb-66aa-e063-6294a90a5f2b
spl set id: 2055289d-962e-46a9-b371-b5bb93dd46b4

Reported adverse events (FAERS/openFDA)#

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