MedPath

Witch Hazel

HEB 822.001/822AA Witch Hazel

Approved
Approval ID

09b814f4-86b5-4810-bf52-cc88396451c2

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Jun 18, 2025

Manufacturers
FDA

H-E-B

DUNS: 007924756

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 Code37808-822
Application NumberM015
Product Classification
M
Marketing Category
C200263
G
Generic Name
Witch Hazel
Product Specifications
Route of AdministrationTOPICAL
Effective DateJune 18, 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: 6/18/2025

principal display panel

H-E-B ®

Witch Hazel U.S.P.

Astringent

  • Cleans & Refreshes
  • For Relief of Minor Skin Irritations due to - Insects Bites - Minor Cuts - Minor Scrapes

16 FL OZ (1 PTP) 473 mL

image descriptionimage description

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 6/18/2025

Use

for relief of minor skin irritations due to:

  • insect bites
  • minor cuts
  • minor scrapes

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 6/18/2025

adverse reaction

DISTRIBUTED BY: H-E-B ®, SAN ANTONIO, TX 78204

LOT NUMBER: ON PACKAGE

QUESTIONS? 1-888-593-0593

H-E-B ® 100% GUARANTEE promise

If you aren't completely pleased with this product, we'll be happy to replace it or refund your money.

You have our word on it.

Pat. D675, 101

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 6/18/2025

Active ingredient

Witch Hazel 86%

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

LOINC: 50565-1Updated: 6/18/2025

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: 6/18/2025

Directions

apply as often as needed

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 6/18/2025

Inactive ingredient

alcohol 14% by volume

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 6/18/2025

Purpose

Astringent

WARNINGS SECTION

LOINC: 34071-1Updated: 6/18/2025

Warnings

For external use only

OTC - WHEN USING SECTION

LOINC: 50567-7Updated: 6/18/2025

When using this product

avoid contact with the eyes

OTC - STOP USE SECTION

LOINC: 50566-9Updated: 6/18/2025

Stop use and ask a doctor if

  • condition worsens or symptoms persist for more than 7 days

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