Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 1953ec64-20ce-488b-8f14-44e15cc9e720
Route
TOPICAL
Published
Effective Date 2020-11-05
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (5 g)
Inactive Ingredients
Aloe Vera Leaf Anhydrous Citric Acid Capryl/capramidopropyl Betaine Diazolidinyl Urea Glycerin Methylparaben Propylene Glycol Propylparaben Sodium Citrate, Unspecified Form Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2010-11-21

Description

Active ingredient Witch hazel 50%


Medication Information

Warnings and Precautions

Warnings

For external use only

Indications and Usage

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • aids in protecting irritated anorectal areas
Dosage and Administration

Directions

  • adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
  • children under 12 years of age: consult a doctor
Description

Active ingredient Witch hazel 50%

Section 44425-7

Other information

  • for best results, flush only one wipe at a time
  • store at 20-25°C (68-77°F)
Section 50565-1

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Section 53413-1

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374.

For most recent product information, visit www.preparationh.com.

Section 55105-1

Purpose

Astringent

Section 55106-9

Active ingredient

Witch hazel 50%

Principal Display Panel

PREPARATION H ®

MEDICATED

HEMORRHOIDAL

WIPES

WITH WITCH HAZEL

MAXIMUM STRENGTH FORMULA

WITH

ALOE

Tōtables ®

Irritation Relief

10 INDIVIDUALLY WRAPPED FLUSHABLE WIPES

5.375 x 6.25 in. (13.6 x 15.8 cm)

When Using This Product
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into the rectum by using fingers or any mechanical device or applicator
Stop Use and Ask A Doctor If
  • bleeding occurs
  • condition worsens or does not improve within 7 days

Structured Label Content

Indications and Usage (34067-9)

Uses

  • helps relieve the local itching and discomfort associated with hemorrhoids
  • temporary relief of irritation and burning
  • aids in protecting irritated anorectal areas
Dosage and Administration (34068-7)

Directions

  • adults: unfold wipe and cleanse the area by gently wiping, patting or blotting. If necessary, repeat until all matter is removed from the area.
  • use up to 6 times daily or after each bowel movement and before applying topical hemorrhoidal treatments, and then discard
  • children under 12 years of age: consult a doctor
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • for best results, flush only one wipe at a time
  • store at 20-25°C (68-77°F)
Section 50565-1 (50565-1)

Keep out of reach of children.If swallowed, get medical help or contact a Poison Control Center right away.

Section 51727-6 (51727-6)

Inactive ingredients

aloe barbadensis leaf juice, anhydrous citric acid, capryl/capramidopropyl betaine, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Section 53413-1 (53413-1)

Questions or comments?

Call weekdays 9 AM to 5 PM EST at 1-800-99PrepHor 1-800-997-7374.

For most recent product information, visit www.preparationh.com.

Section 55105-1 (55105-1)

Purpose

Astringent

Section 55106-9 (55106-9)

Active ingredient

Witch hazel 50%

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

PREPARATION H ®

MEDICATED

HEMORRHOIDAL

WIPES

WITH WITCH HAZEL

MAXIMUM STRENGTH FORMULA

WITH

ALOE

Tōtables ®

Irritation Relief

10 INDIVIDUALLY WRAPPED FLUSHABLE WIPES

5.375 x 6.25 in. (13.6 x 15.8 cm)

When Using This Product (When using this product)
  • do not exceed the recommended daily dosage unless directed by a doctor
  • do not put this product into 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)
  • bleeding occurs
  • condition worsens or does not improve within 7 days

Advanced Ingredient Data


Raw Label Data

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