MedPath
FDA Approval

Witch Hazel

Pharmacy Vlaue Alliance LLC (DUNS: 101668460)

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

Pharmacy Vlaue Alliance LLC

Consumer Product Partners, LLC

119091514

Products (1)

Witch Hazel

68016-822

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 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

use

for relief of minor skin irritations due to:

  • insects bites
  • minor cuts
  • minor scrapes

DOSAGE & ADMINISTRATION SECTION

Directions

apply as often as needed


WARNINGS SECTION

Warnings

For external use only


ADVERSE REACTIONS SECTION

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 - 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 worsens or symptoms persist for more than 7 days

OTC - WHEN USING SECTION

When using this product

  • avoid contact with the eyes

OTC - QUESTIONS SECTION

Questions?

Call 1-888-593-0593


SPL UNCLASSIFIED SECTION

Disclaimer

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

INACTIVE INGREDIENT SECTION

inactive ingredients

alcohol 14% by volume


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