drug facts

drug facts
SPL v4
SPL
SPL Set ID 485437a8-b2e9-4acf-a20e-edb1f08a9cae
Route
topical
Published
Effective Date 2021-03-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
witch hazel (200 mg)
Inactive Ingredients
aloe vera leaf anhydrous citric acid glycerin propylene glycol sodium citrate, unspecified form water benzyl alcohol edetate disodium sodium benzoate

Identifiers & Packaging

Marketing Status
otc monograph drug completed Since 2020-03-04 Until 2026-12-31

Purpose

Astringent

Description

Drug Facts


Medication Information

Warnings

For external use only

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

Astringent

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
Other Information
  • for best results, flush only one wipe at a time
  • store at 20-25°C (68-77°F)
Inactive Ingredients

aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, edetate disodium, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate

Description

Drug Facts

Section 42229-5

Drug Facts

Section 50565-1

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

Active Ingredient

Witch hazel 20%

Questions Or Comments?

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

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
Principal Display Panel 60 Wipe Pouch

NEW!

PREPARATION H ®

soothing

RELIEF

cleansing & cooling

wipes

PEEL HERE

HEMORRHOIDAL WIPES

with WITCH HAZEL

Cools on Contact

Gentle for Daily Use

With Aloe

Flushable

60

WIPES

6 x 5 in. (15.2 x 12.7cm)

Principal Display Panel 60 Wipe Pouch Carton

180

WIPES

3 PACKS

PREPARATION H ®

soothing

RELIEF

cleansing & cooling

wipes

HEMORRHOIDAL WIPES

with WITCH HAZEL

Cools on Contact

Gentle for Daily Use

With Aloe

Flushable

3 x 60

COUNT

POUCHES

6 x 5 in. (15.2 x 12.7 cm)


Structured Label Content

Warnings

For external use only

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

Astringent

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
Other Information (Other information)
  • for best results, flush only one wipe at a time
  • store at 20-25°C (68-77°F)
Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, anhydrous citric acid, benzyl alcohol, edetate disodium, glycerin, propylene glycol, purified water, sodium benzoate, sodium citrate

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

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

Active Ingredient (Active ingredient)

Witch hazel 20%

Questions Or Comments? (Questions or comments?)

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

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
Principal Display Panel 60 Wipe Pouch (PRINCIPAL DISPLAY PANEL - 60 Wipe Pouch)

NEW!

PREPARATION H ®

soothing

RELIEF

cleansing & cooling

wipes

PEEL HERE

HEMORRHOIDAL WIPES

with WITCH HAZEL

Cools on Contact

Gentle for Daily Use

With Aloe

Flushable

60

WIPES

6 x 5 in. (15.2 x 12.7cm)

Principal Display Panel 60 Wipe Pouch Carton (PRINCIPAL DISPLAY PANEL - 60 Wipe Pouch Carton)

180

WIPES

3 PACKS

PREPARATION H ®

soothing

RELIEF

cleansing & cooling

wipes

HEMORRHOIDAL WIPES

with WITCH HAZEL

Cools on Contact

Gentle for Daily Use

With Aloe

Flushable

3 x 60

COUNT

POUCHES

6 x 5 in. (15.2 x 12.7 cm)


Advanced Ingredient Data


Raw Label Data

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