Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 53e39d22-a89e-4f95-8c64-abeb50f72ce7
Route
TOPICAL
Published
Effective Date 2019-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (500 mg)
Inactive Ingredients
Water Sodium Citrate Citric Acid Monohydrate Glycerin Phenoxyethanol Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-06-28

Description

Witch Hazel 50%

Purpose

Hemorrhoidal Astringent


Medication Information

Purpose

Hemorrhoidal Astringent

Description

Witch Hazel 50%

Uses

Temporarily relieves these external symptoms associated with hemorrhoids:

  • itching
  • burning
  • irritation
Section 42229-5

* This product is not manufactured or distributed by Blistex, Inc., owner of the registered trademark TUCKS®.

Section 60561-8

Do not use this product if seal on jar is broken or missing.

Warnings

For external rectal use only.

Directions

As hemorrhoidal treatment for adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • gently apply to the affected area by patting and then discard.
  • can be used up to six times daily or after each bowel movement.

Children under 12 years of age

  • consult a doctor.
Active Ingredient

Witch Hazel 50%

Other Information

Store at controlled room temperature: 15º-30ºC (59º-86ºF)

Inactive Ingredients

Water, Sodium citrate, Citric acid, Glycerin, Phenoxyethanol, Potassium sorbate

Principal Display Panel

NDC 41250-868-10

meijer

Compare to Tucks

hemorrhoidal pads

Medicated Cool Relief with Witch Hazel

MAXIMUM STRENGTH

100 PADS 3 IN DIA (7.62 cm DIA)

DO NOT FLUSH

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • do not insert into rectum or vagina using fingers or mechanical device.
Stop Use and Ask A Doctor If
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days.
Keep Out of Reach of Children.

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


Structured Label Content

Uses

Temporarily relieves these external symptoms associated with hemorrhoids:

  • itching
  • burning
  • irritation
Section 42229-5 (42229-5)

* This product is not manufactured or distributed by Blistex, Inc., owner of the registered trademark TUCKS®.

Section 60561-8 (60561-8)

Do not use this product if seal on jar is broken or missing.

Purpose

Hemorrhoidal Astringent

Warnings

For external rectal use only.

Directions

As hemorrhoidal treatment for adults:

  • when practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.
  • gently dry by patting or blotting with toilet tissue or soft cloth before applying.
  • gently apply to the affected area by patting and then discard.
  • can be used up to six times daily or after each bowel movement.

Children under 12 years of age

  • consult a doctor.
Active Ingredient

Witch Hazel 50%

Other Information

Store at controlled room temperature: 15º-30ºC (59º-86ºF)

Inactive Ingredients

Water, Sodium citrate, Citric acid, Glycerin, Phenoxyethanol, Potassium sorbate

Principal Display Panel

NDC 41250-868-10

meijer

Compare to Tucks

hemorrhoidal pads

Medicated Cool Relief with Witch Hazel

MAXIMUM STRENGTH

100 PADS 3 IN DIA (7.62 cm DIA)

DO NOT FLUSH

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor.
  • do not insert into rectum or vagina using fingers or mechanical device.
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • rectal bleeding occurs
  • condition worsens or does not improve within 7 days.
Keep Out of Reach of Children. (Keep out of reach of children.)

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


Advanced Ingredient Data


Raw Label Data

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