drug facts

drug facts
SPL v5
SPL
SPL Set ID 36deb7de-14b0-44a4-89bb-51cc1770e65b
Route
topical
Published
Effective Date 2025-02-04
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
witch hazel (842 mg)
Inactive Ingredients
alcohol

Identifiers & Packaging

Marketing Status
otc monograph drug active Since 2022-09-30

Purpose

Astringent

Description

Witch hazel, USP 86%


Medication Information

Warnings

For external use only.

  • Avoid swallowing.
Uses
  • for relief of minor skin irritations due to:
    • insect bites
    • minor cuts
    • minor scrapes
Purpose

Astringent

Directions

apply to the affected area as often as necessary.

Other Information
  • keep tightly closed
  • store at room temperature
Description

Witch hazel, USP 86%

Principal Display Panel

COMPARE TOT.N. DICKINSON'S® WITCH HAZEL active ingredient*

Witch Hazel

USP, 86% | Astringent

Alcohol 14% by Volume

Hamamelis Water

For relief of

Minor Skin Irritations

Due To:

Insect Bites

Minor Cuts

Minor Scrapes

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DIST. BY

CAH DUBLIN, OH 43017

www.myleader.com

Package Label
LEADER Witch Hazel
Active Ingredient

Witch hazel, USP 86%

Inactive Ingredient

alcohol 14% by volume

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

When Using This Product

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If

condition worsens or symptoms persist for more than 7 days

If Pregnant Or Breast Feeding,

ask a health professional before use.

Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away..


Structured Label Content

Warnings

For external use only.

  • Avoid swallowing.
Uses
  • for relief of minor skin irritations due to:
    • insect bites
    • minor cuts
    • minor scrapes
Purpose

Astringent

Directions

apply to the affected area as often as necessary.

Other Information (Other information)
  • keep tightly closed
  • store at room temperature
Principal Display Panel

COMPARE TOT.N. DICKINSON'S® WITCH HAZEL active ingredient*

Witch Hazel

USP, 86% | Astringent

Alcohol 14% by Volume

Hamamelis Water

For relief of

Minor Skin Irritations

Due To:

Insect Bites

Minor Cuts

Minor Scrapes

FL OZ (mL)

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

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

DIST. BY

CAH DUBLIN, OH 43017

www.myleader.com

Package Label
LEADER Witch Hazel
Active Ingredient (Active ingredient)

Witch hazel, USP 86%

Inactive Ingredient (Inactive ingredient)

alcohol 14% by volume

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

When Using This Product (When using this product)

avoid contact with eyes. If contact occurs, rinse thoroughly with water.

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

condition worsens or symptoms persist for more than 7 days

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (Keep out of reach of children.)

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away..


Advanced Ingredient Data


Raw Label Data

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