FDA.reportPublic FDA data

TN Dickinsons Medicated Cooling Foam Hemorrhoidal Relief

Manufacturer
Dickinson Brands Inc. | American Distilling Inc.
Effective date
2025-06-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:05:58

Label at a glance#

ProductTN Dickinsons Medicated Cooling Foam Hemorrhoidal Relief
Active ingredientWITCH HAZEL
Label structure11 sections

Indications and uses

helps relieve local burning, itching and discomfort associated with hemorrhoids and perineal area aids in the protection of irritated or inflamed anorectal areas

Dosage and administration

adults: when practical, cleanse the affected area with mild soap & warm water and rinse thoroughly gently dry by blotting with toilet tissue or soft cloth before application pump once onto toilet paper & if desired, fold to deflate foam. Apply to affected area by patting then flush. postpartum, add foam on top of each maxi pad for healing relief. use up to 6 times daily or after each bowel movement children under ...

Storage and handling

pack foam in hospital bag for instant relief post-delivery and place in bathroom for at home recovery. store at room temperature or in fridge for extra cooling.

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

All natural distilled witch hazel 50% (including natural grain alcohol)

Purpose

OTC - PURPOSE SECTION

Astringent

Uses

INDICATIONS & USAGE SECTION

  • helps relieve local burning, itching and discomfort associated with hemorrhoids and perineal area
  • aids in the protection of irritated or inflamed anorectal areas

Warnings

WARNINGS SECTION

For external use only

OTC - WHEN USING SECTION

When using this product

  • do not exceed recommended dosage unless recommended by a physician
  • do not put this product into rectum by using fingers or any mechanical device or applicator

OTC - STOP USE SECTION

Stop use and ask doctor if

  • condition worsens or does not improve within 7 days
  • bleeding occurs

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. If swallowed, get medical help or contact Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • adults: when practical, cleanse the affected area with mild soap & warm water and rinse thoroughly
  • gently dry by blotting with toilet tissue or soft cloth before application
  • pump once onto toilet paper & if desired, fold to deflate foam. Apply to affected area by patting then flush.
  • postpartum, add foam on top of each maxi pad for healing relief.
  • use up to 6 times daily or after each bowel movement
  • children under 12 years of age: consult a doctor

Other information

STORAGE AND HANDLING SECTION

  • pack foam in hospital bag for instant relief post-delivery and place in bathroom for at home recovery.
  • store at room temperature or in fridge for extra cooling.

Inactive ingredients

INACTIVE INGREDIENT SECTION

aloe barbadensis leaf juice, coco glucoside, glycerin, lactic acid, propanediol, purified water, sodium benzoate

QUESTIONS OR COMMENTS?

OTC - QUESTIONS SECTION

TNDickinsons.com
1•888•860•2279

SPL UNCLASSIFIED SECTION

Dist. by: Dickinson Brands Inc.
East Hampton, CT 06424

PRINCIPAL DISPLAY PANEL - 147 mL Bottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

#1 PHYSICIAN RECOMMENDED*
WITCH HAZEL BRAND

T.N.
DICKINSON'S®

Witch
hazel®

NEW
Medicated Cooling Foam

HEMORRHOIDAL RELIEF

Immediately Soothes
Inflamed, burning, itching
Hemorrhoidal, Vaginal &
Postpartum Perineal areas

MADE WITH
100% NATURAL
WITCH HAZEL

HEMORRHOIDAL WIPE ALTERNATIVE

5 FL. OZ. (147 mL) = Approx. 185 Wipes or Pads

Learn More!

PRINCIPAL DISPLAY PANEL - 147 mL Bottle Label
PRINCIPAL DISPLAY PANEL - 147 mL Bottle Label

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
52651-057-01TN Dickinsons Medicated Cooling Foam Hemorrhoidal Relief50 mL in 1 BOTTLE, PUMPLIQUID502
52651-057-02TN Dickinsons Medicated Cooling Foam Hemorrhoidal Relief147 mL in 1 BOTTLE, PUMPLIQUID1472

Products#

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

DailyMed product names page 1 of 1 · 9 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
52651-05752651-057-02, 52651-057-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 8 matching rows.

Name, UNII, Kind table
NameUNIIKind
WITCH HAZEL101I4J0U34ACTIB
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
PROPANEDIOL5965N8W85TIACT
SODIUM BENZOATEOJ245FE5EUIACT
ALOE VERA LEAFZY81Z83H0XIACT
LACTIC ACID, UNSPECIFIED FORM33X04XA5ATIACT
COCO-GLUCOSIDEICS790225BIACT

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
TN Dickinsons Medicated Cooling Foam Hemorrhoidal ReliefWITCH HAZELDickinson Brands Inc.deca8ae2-53a3-4c90-aa10-45354e2cdab82025-06-27WarningsExact identifier
ndc (package): 52651-057-02
ndc (package): 52651-057-01
ndc (product): 52651-057
ndc11 (package): 52651005701
ndc11 (package): 52651005702
spl id: 6db86657-18c0-476f-9542-34847c545307
spl set id: deca8ae2-53a3-4c90-aa10-45354e2cdab8

Reported adverse events (FAERS/openFDA)#

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