Drug Facts

Drug Facts
SPL v5
SPL
SPL Set ID a2047ef3-cda4-4411-a4c2-d7fb03f5b069
Route
TOPICAL
Published
Effective Date 2025-02-06
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 2017-12-31

Description

Witch hazel 86%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch hazel 86%

Uses
  • for relief of minor skin irritations due to:
    • insect bites
    • minor cuts
    • minor scrapes
Warnings
  • for external use only
  • avoid swallowing
Directions

apply to the affected area as often as necessary.

Package Label
MODESA-FAMILY WELLNESS Witch Hazel
Active Ingredient

Witch hazel 86%

Other Information
  • keep tightly closed
  • store at room temperature
Inactive Ingredient

alcohol 14% by volume

Principal Display Panel

Modesa

ASTRINGENT

WITCH HAZEL

For Face and Body

SOOTHES MINOR SKIN IRRITATIONS

ALCOHOL 14% BY VOLUME

FL OZ (mL)

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD, MATTHEWS, NC 28105

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

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

Astringent

Warnings
  • for external use only
  • avoid swallowing
Directions

apply to the affected area as often as necessary.

Package Label
MODESA-FAMILY WELLNESS Witch Hazel
Active Ingredient (Active ingredient)

Witch hazel 86%

Other Information (Other information)
  • keep tightly closed
  • store at room temperature
Inactive Ingredient (Inactive ingredient)

alcohol 14% by volume

Principal Display Panel

Modesa

ASTRINGENT

WITCH HAZEL

For Face and Body

SOOTHES MINOR SKIN IRRITATIONS

ALCOHOL 14% BY VOLUME

FL OZ (mL)

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

DISTRIBUTED BY: MIDWOOD BRANDS, LLC

10611 MONROE RD, MATTHEWS, NC 28105

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

All Sections (JSON)