Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 1b50f4dc-c26a-431a-ae18-c43513871b39
Route
TOPICAL
Published
Effective Date 2019-11-27
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (1.2 g)
Inactive Ingredients
Water Glycerin Alcohol Benzethonium Chloride Methylparaben Aloe Vera Leaf

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 1994-12-01

Description

Active ingredient Witch hazel 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Active ingredient Witch hazel 50%

Uses
  • helps relieve local burning, itching, and discomfort associated with hemorrhoids
  • aids in the protection of irritated or inflamed anorectal areas

Section 50565-1

Keep out of reach of children. If swallowed, get medical

help or contact Poison Control Center right away.

Section 50566-9

Stop use and ask doctor if

  • condition worsens or does not improve within 7 days
  • bleeding occurs

Section 53413-1

Questions or Comments? Call toll free: 1-888-860-2279 or Visit tndickinsons.com

Dist. by: Dickinson Brands Inc, East Hampton, CT 06424

Section 55106-9

Active ingredient

Witch hazel 50%

Warnings:

For external use only

When using this product

  • do not exceed recommended dosage unless recommended by a physician
  • do not put this product into rectum by using fingers or any mechanical device or applicator





Directions
  • adults: cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by blotting with toilet tissue or soft cloth before application
  • apply product to affected area by patting and then discard
  • use up to 6 times daily or after each bowel movement
  • children under 12 years of age:consult a doctor

Product Packaging

Cleanse, Soothe Treat



T.N. DICKINSON'S Witch hazel



Hemorrhoidal Pads with Aloe

Relieves Hemorrhoidal

and Vaginal Irritation

Cools and Comforts













Inactive Ingredients

purified water, glycerin, Alcohol 7%, benzethonium chloride, methylparaben, and aloe barbadensis leaf juice


Structured Label Content

Uses
  • helps relieve local burning, itching, and discomfort associated with hemorrhoids
  • aids in the protection of irritated or inflamed anorectal areas

Section 50565-1 (50565-1)

Keep out of reach of children. If swallowed, get medical

help or contact Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask doctor if

  • condition worsens or does not improve within 7 days
  • bleeding occurs

Section 53413-1 (53413-1)

Questions or Comments? Call toll free: 1-888-860-2279 or Visit tndickinsons.com

Dist. by: Dickinson Brands Inc, East Hampton, CT 06424

Section 55106-9 (55106-9)

Active ingredient

Witch hazel 50%

Purpose

Astringent

Warnings:

For external use only

When using this product

  • do not exceed recommended dosage unless recommended by a physician
  • do not put this product into rectum by using fingers or any mechanical device or applicator





Directions
  • adults: cleanse the affected area with mild soap and warm water and rinse thoroughly
  • gently dry by blotting with toilet tissue or soft cloth before application
  • apply product to affected area by patting and then discard
  • use up to 6 times daily or after each bowel movement
  • children under 12 years of age:consult a doctor

Product Packaging

Cleanse, Soothe Treat



T.N. DICKINSON'S Witch hazel



Hemorrhoidal Pads with Aloe

Relieves Hemorrhoidal

and Vaginal Irritation

Cools and Comforts













Inactive Ingredients (Inactive ingredients)

purified water, glycerin, Alcohol 7%, benzethonium chloride, methylparaben, and aloe barbadensis leaf juice


Advanced Ingredient Data


Raw Label Data

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