Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID b3bc469e-15cc-4679-8ca9-01d77586473e
Route
TOPICAL
Published
Effective Date 2020-03-31
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH FINAL Active Since 2020-03-31

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 60561-8

Flush only one wipe at a time. Keep lid tightly closed when not in use.

Gently pull out wipe to dispense

Safe for well-maintained sewers and septic systems

Not recommended for use with basement pump systems

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 30142-314-48

COMPARE TO the active ingredient of PREPARATION H® MEDICATED WIPES

*See back panel

Kroger®

MAXIMUM STRENGTH

Flushable Hemorrhoidal Medicated Wipes

Witch Hazel, 50%

Gentle Everyday Cleansing to Reduce Irritation

With Aloe

PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

48 MEDICATED WIPES 6.0 IN x 5.0 IN (15.2 cm x 12.7 cm)

NDC 30142-314-96

COMPARE TO the active ingredient of PREPARATION H® MEDICATED WIPES

*See bottom panel

Kroger®

MAXIMUM STRENGTH

Flushable Hemorrhoidal Medicated Wipes

Witch Hazel, 50%

Gentle Everyday Cleansing to Reduce Irritation

With Aloe

PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

2 X 48 CT PACKS

96 MEDICATED WIPES

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 60561-8 (60561-8)

Flush only one wipe at a time. Keep lid tightly closed when not in use.

Gently pull out wipe to dispense

Safe for well-maintained sewers and septic systems

Not recommended for use with basement pump systems

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 30142-314-48

COMPARE TO the active ingredient of PREPARATION H® MEDICATED WIPES

*See back panel

Kroger®

MAXIMUM STRENGTH

Flushable Hemorrhoidal Medicated Wipes

Witch Hazel, 50%

Gentle Everyday Cleansing to Reduce Irritation

With Aloe

PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

48 MEDICATED WIPES 6.0 IN x 5.0 IN (15.2 cm x 12.7 cm)

NDC 30142-314-96

COMPARE TO the active ingredient of PREPARATION H® MEDICATED WIPES

*See bottom panel

Kroger®

MAXIMUM STRENGTH

Flushable Hemorrhoidal Medicated Wipes

Witch Hazel, 50%

Gentle Everyday Cleansing to Reduce Irritation

With Aloe

PRE˜MOISTENED Cools, Soothes & Comforts Convenient, Easy to Use

2 X 48 CT PACKS

96 MEDICATED WIPES

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


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