Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID acd0d99d-2a77-4227-bebb-c819f4a52666
Route
TOPICAL
Published
Effective Date 2020-05-26
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (50 mg)
Inactive Ingredients
Water Aloe Vera Leaf Sodium Citrate Citric Acid Monohydrate Glycerin Phenoxyethanol Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2020-05-15

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
Warnings

For external 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, Aloe Barbadensis Leaf Extract, Sodium Citrate, Citric Acid, Glycerin, Phenoxyethanol, Potassium Sorbate

Principal Display Panel

NDC 11673-614-10

Compare to Tucks ®​​*

medicated pads

cooling hemmorhoidal relief

soothing witch hazel helps protect irritated areas

pH balanced

100 PADS

3 IN X 3 IN (7.6 cm X 7.6 cm)

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
Purpose

Hemorrhoidal Astringent

Warnings

For external 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, Aloe Barbadensis Leaf Extract, Sodium Citrate, Citric Acid, Glycerin, Phenoxyethanol, Potassium Sorbate

Principal Display Panel

NDC 11673-614-10

Compare to Tucks ®​​*

medicated pads

cooling hemmorhoidal relief

soothing witch hazel helps protect irritated areas

pH balanced

100 PADS

3 IN X 3 IN (7.6 cm X 7.6 cm)

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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