FDA.reportPublic FDA data

AER

Manufacturer
Birchwood Laboratories LLC
Effective date
2025-01-14
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:52:32

Label at a glance#

ProductAER Pre-moistened Witch Hazel Pad
Active ingredientWITCH HAZEL
Label structure8 sections

Indications and uses

Temporary relief of anal itching and burning Temporarily protects irritated tissues

Dosage and administration

Gently apply to affected areas by patting and then discard

Label contents#

Full prescribing information#

Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

Witch Hazel 50%

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

Temporary relief of anal itching and burning

Temporarily protects irritated tissues

Warnings

WARNINGS SECTION

For external rectal use only

Stop use and ask doctor if

rectal bleeding or continued irritation occurs

Keep Out Of Reach of Children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children

Directions

DOSAGE & ADMINISTRATION SECTION

Gently apply to affected areas by patting and then discard

Inactive Ingredients

INACTIVE INGREDIENT SECTION

Benzalkonium Chloride, Citric Acid, Glycerin, Methylparaben, Purified Water, Sodium Citrate

AER Lid

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

AER LidAER Lid

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1247719A.E.R. 50 % Medicated PadPSN6
844379witch hazel 50 % Medicated PadPSN6
1247719witch hazel 500 MG/ML Medicated Pad [A.E.R. Witch Hazel]SBD6
844379witch hazel 500 MG/ML Medicated PadSCD6
1247719A.E.R. 50 % Medicated PadSY6
1247719A.E.R. Witch Hazel 500 MG/ML Medicated PadSY6
844379witch hazel 50 % Medicated PadSY6
844379witch hazel 50 % Medicated WipesSY6

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 Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50289-3250-1AERPre-moistened Witch Hazel Pad40 in 1 JARSOLUTION406
50289-3250-1AERPre-moistened Witch Hazel Pad2.8 mL in 1 APPLICATORSOLUTION2.86

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50289-3250AER PRE-MOISTENED WITCH HAZEL PAD (WITCH HAZEL) SOLUTION [BIRCHWOOD LABORATORIES LLC]6Current NDC, Legacy NDC, 2 package rows20250115_1cca622f-0a6b-4f35-9355-34c249ee705e.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
50289-3250-1EA - Each50289-3250c05692d4-5d66-4fbc-aafa-1ed8ae419bed12012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
Witch HazelACTIVE INGREDIENT101I4J0U341
Witch HazelACTIVE MOIETY101I4J0U341
ANHYDROUS CITRIC ACIDINACTIVE INGREDIENTXF417D3PSL1
Benzalkonium ChlorideINACTIVE INGREDIENTF5UM2KM3W71
GlycerinINACTIVE INGREDIENTPDC6A3C0OX1
MethylparabenINACTIVE INGREDIENTA2I8C7HI9T1
Sodium CitrateINACTIVE INGREDIENT1Q73Q2JULR1
WaterINACTIVE INGREDIENT059QF0KO0R1

Products#

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

DailyMed product names page 1 of 1 · 8 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50289-325050289-3250-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 7 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34ACTIB
GLYCERINPDC6A3C0OXIACT
WATER059QF0KO0RIACT
METHYLPARABENA2I8C7HI9TIACT
BENZALKONIUM CHLORIDEF5UM2KM3W7IACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT
SODIUM CITRATE1Q73Q2JULRIACT

Source Document#

Source XML

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 · 10 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
GlycerinGLYCERINPDC6A3C0OXSOLUTION / TOPICAL1971 mgExact identifier — unii+route+dosage form
2 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / TOPICAL216 mgExact identifier — unii+route+dosage form
4 equally ranked IID candidates
MethylparabenMETHYLPARABENA2I8C7HI9TSOLUTION / RECTAL0.13 %w/vExact identifier — unii+route+dosage form
4 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
Benzalkonium ChlorideBENZALKONIUM CHLORIDEF5UM2KM3W7SOLUTION / TOPICAL0.02 %w/vExact identifier — unii+route+dosage form
2 equally ranked IID candidates
ANHYDROUS CITRIC ACIDANHYDROUS CITRIC ACIDXF417D3PSLSOLUTION / TOPICAL4.35 %w/vExact 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
AER Pre-moistened Witch Hazel PadWITCH HAZELBirchwood Laboratories LLC1cca622f-0a6b-4f35-9355-34c249ee705e2025-01-14WarningsExact identifier
ndc (package): 50289-3250-1
ndc (product): 50289-3250
ndc11 (package): 50289325001
spl id: 2baae3c5-a04e-c51e-e063-6394a90a81c3
spl set id: 1cca622f-0a6b-4f35-9355-34c249ee705e

Reported adverse events (FAERS/openFDA)#

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