MedPath
FDA Approval

Witch Hazel

Publix Super Markets, Inc (DUNS: 006922009)

June 23, 2025

HUMAN OTC DRUG LABEL

Witch hazel(860 mg in 1 mL)

Registrants (1)

Consumer Product Partners, LLC

119091520

Manufacturing Establishments (1)

Consumer Product Partners, LLC

Publix Super Markets, Inc

Consumer Product Partners, LLC

119091514

Products (1)

Witch Hazel

56062-822

M016

OTC Monograph Drug (C200263)

TOPICAL

June 23, 2025

ALCOHOLInactive
Code: 3K9958V90MClass: IACT
Code: 101I4J0U34Class: ACTIBQuantity: 860 mg in 1 mL

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

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INDICATIONS & USAGE SECTION

Use

for relief of minor skin irritations due to:

  • insects bites
  • minor cuts
  • monor scrapes

DOSAGE & ADMINISTRATION SECTION

Directions

apply as often as needed


WARNINGS SECTION

Warnings

For external use only


ADVERSE REACTIONS SECTION

ADVERSE REACTION

Distributed by Publix Supermarkets, Inc.

3300 Publix Corporate Parkway

Lakeland, FL 33811 publix.com


OTC - ACTIVE INGREDIENT SECTION

Active ingredient

Witch Hazel 86%

OTC - PURPOSE SECTION

Purpose

Astringent

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

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

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • condition worses or symptoms last for more than 7 days

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes

SPL UNCLASSIFIED SECTION

Disclaimer

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

INACTIVE INGREDIENT SECTION

Inactive ingredient

alcohol 14% by volume


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