Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 5422b178-c712-40eb-9700-21de357a6dfb
Route
TOPICAL
Published
Effective Date 2011-12-01
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (5 g)
Inactive Ingredients
Water Glycerin Alcohol Propylene Glycol Sodium Citrate Diazolidinyl Urea Citric Acid Monohydrate Methylparaben Propylparaben

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2011-12-01
Description

Witch hazel 50%

Purpose

Astringent

Medication Information

Purpose

Astringent

Description

Witch hazel 50%

Uses
  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves irritation and burning

Warnings

For external use only.

Directions

Adults:

  • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • after application, discard pad

Children under 12 years of age: ask a doctor

Package Label

Hemorrhoidal Pads

Active Ingredient

Witch hazel 50%

Other Information
  • Store at 68° - 77°F (20° - 25°C)

Inactive Ingredients

water, glycerin, alcohol, propylene glycol, sodium citrate, diazolidinyl urea, citric acid, methylparaben, propylparaben

When Using This Product
  • do not use more than directed unless told to do so by a doctor
  • do not put directly in the rectum by using fingers or any mechanical device or applicator

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.

Structured Label Content

Uses
  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves irritation and burning

Purpose

Astringent

Warnings

For external use only.

Directions

Adults:

  • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • after application, discard pad

Children under 12 years of age: ask a doctor

Package Label (Package label)

Hemorrhoidal Pads

Active Ingredient (Active ingredient)

Witch hazel 50%

Other Information (Other information)
  • Store at 68° - 77°F (20° - 25°C)

Inactive Ingredients (Inactive ingredients)

water, glycerin, alcohol, propylene glycol, sodium citrate, diazolidinyl urea, citric acid, methylparaben, propylparaben

When Using This Product (When using this product)
  • do not use more than directed unless told to do so by a doctor
  • do not put directly in the rectum by using fingers or any mechanical device or applicator

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.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:18.966628 · Updated: 2026-03-14T22:54:41.714370