Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID 209a111b-d169-cb5d-e063-6394a90a33ca
Route
TOPICAL
Published
Effective Date 2010-04-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-04-18

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

aloe barbadensis leaf extract, citric acid, glycerin, phenoxyethanol, potassium sorbate, sodium citrate, water

Principal Display Panel

NDC 0363-1740-48

Walgreens

Compare to the active ingredient in Preparation H® Medicated Wipes*

Pre-Moistened Medicated Wipes

WITCH HAZEL 50%/HEMORRHOIDAL ASTRINGENT

Maximum Strength

Cooling Relef

+Aloe

Witch hazel & aloe soothe & provide temporary relief of hemorrhoidal irritation & burning

Protects irritated areas

Easy to Use

48 WIPES

6 IN X 5 IN (15.2 cm X 12.7 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

aloe barbadensis leaf extract, citric acid, glycerin, phenoxyethanol, potassium sorbate, sodium citrate, water

Principal Display Panel

NDC 0363-1740-48

Walgreens

Compare to the active ingredient in Preparation H® Medicated Wipes*

Pre-Moistened Medicated Wipes

WITCH HAZEL 50%/HEMORRHOIDAL ASTRINGENT

Maximum Strength

Cooling Relef

+Aloe

Witch hazel & aloe soothe & provide temporary relief of hemorrhoidal irritation & burning

Protects irritated areas

Easy to Use

48 WIPES

6 IN X 5 IN (15.2 cm X 12.7 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

All Sections (JSON)