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Witch Hazel

Premier Value 822.001/822AA Witch Hazel

Approved
Approval ID

161de71d-c919-4e12-80a4-dc4e394f9ff7

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 23, 2025

Manufacturers
FDA

Pharmacy Vlaue Alliance LLC

DUNS: 101668460

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 Code68016-822
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 Panel Display

COMPARE TO T.N.DICKINSON'S ®*

Premier Value ®

Witch Hazel u.s.p.

astringent

hamamelis water

for relief of minor skin irritations due to:

  • insects bites
  • minor cuts
  • minor scrapes

Square bottle uses less plastic than a similarly sized round bottle

Recyclable (if available in your area)

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
  • minor scrapes

ADVERSE REACTIONS SECTION

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

ADVERSE REACTION

If for any reason you are not satisfied with this product, please return it to the store where purchased for a full refund.

Distributed by: Phamacy Value Alliance LLC

407 East Lancaster Avenue, Wayne, PA 19087

www.emersongroup.com

Pat. D675, 101

OTC - STOP USE SECTION

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

Stop use and ask a doctor if

  • condition worsens or symptoms persist 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 ingredients

alcohol 14% by volume

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 6/23/2025

Questions?

Call 1-888-593-0593

OTC - WHEN USING SECTION

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

When using this product

  • avoid contact with the eyes

SPL UNCLASSIFIED SECTION

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

Disclaimer

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

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

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Witch Hazel - FDA Drug Approval Details