MedPath

Witch Hazel

Publix 822.001/822AA Witch Hazel

Approved
Approval ID

0098c983-c518-4a14-8635-c7bdde7bff4f

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 23, 2025

Manufacturers
FDA

Publix Super Markets, Inc

DUNS: 006922009

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

WITCH HAZEL

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code56062-822
Application NumberM016
Product Classification
M
Marketing Category
C200263
G
Generic Name
WITCH HAZEL
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 23, 2025
FDA Product Classification

INGREDIENTS (2)

ALCOHOLInactive
Code: 3K9958V90M
Classification: IACT
WITCH HAZELActive
Quantity: 860 mg in 1 mL
Code: 101I4J0U34
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 6/23/2025

principal display panel

Publix

Distilled Extract

Witch Hazel

Alcohol 14%

Astringent

for relief of minor skin irritations due to: insect bites, minor cuts, scrapes

Compare to TN Dickinson's ®Witch Hazel*

16 FL OZ (1 PT) 473 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/23/2025

Use

for relief of minor skin irritations due to:

  • insects bites
  • minor cuts
  • monor scrapes

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 6/23/2025

ADVERSE REACTION

Distributed by Publix Supermarkets, Inc.

3300 Publix Corporate Parkway

Lakeland, FL 33811 publix.com

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/23/2025

Active ingredient

Witch Hazel 86%

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/23/2025

Purpose

Astringent

WARNINGS SECTION

LOINC: 34071-1Updated: 6/23/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/23/2025

When using this product

  • avoid contact with the eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/23/2025

Stop use and ask a doctor if

  • condition worses or symptoms last for more than 7 days

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/23/2025

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 6/23/2025

Directions

apply as often as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/23/2025

Inactive ingredient

alcohol 14% by volume

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 6/23/2025

Disclaimer

*This product is not manufactured or distributed by Dickinson Brands, Inc., distributor of T.N. Dickinson's Witch Hazel.

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Witch Hazel - FDA Drug Approval Details