Drug Facts

Drug Facts
SPL v9
SPL
SPL Set ID 8d9961f0-1ecf-d7fb-b6b4-856d636d68e1
Route
TOPICAL
Published
Effective Date 2024-08-21
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 2004-02-02

Description

Witch hazel 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch hazel 50%

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

For external use only

Directions
  • open the lid on the top of the wipes pouch
  • peel back wipes seal, remove completely and discard
  • grab the top wipe at the edge of the center fold and pull out of pouch
  • close lid after each use to retain moisture
  • 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 Uses
  • for vaginal care cleanse the area by gently wiping, patting or blotting. Repeat as needed.
  • for use as a moist compress – if necessary, first cleanse the area as previously described. Fold new wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
Generic Section

Preparation H® Medicated Wipes are made with advanced wipe technology, have been scientifically tested to be flushable and are safe for well-maintained sewer and septic systems*. They are made with 100% plant-based materials and are free from chemical binders.

*Not recommended for use with basement pump systems. Flush only one wipe at a time.

Active Ingredient

Witch hazel 50%

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

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

Questions Or Comments?

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

Principle Display Panel

PREPARATION H

MEDICATED

HEMMORHOIDAL

WIPES


WITH WITCH HAZEL

MAXIMUM STRENGTH FORMULA

gentle, everyday cleansing to reduce irritation

WITH ALOE

  • Cools, Soothes, & Comforts
  • Convenient, Easy to Use
  • For Hemorrhoidal & Vaginal Care
  • Flushable & Septic Safe

96 WIPES

6 X 5 in. (15.2 x 12.7 cm)

2-48 COUNT POUCHES

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
Keep Out of Reach of Children.

If swallowed, get medical help or contact a Poison Control Center right away.


Structured Label Content

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

Warnings

For external use only

Directions
  • open the lid on the top of the wipes pouch
  • peel back wipes seal, remove completely and discard
  • grab the top wipe at the edge of the center fold and pull out of pouch
  • close lid after each use to retain moisture
  • 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 Uses
  • for vaginal care cleanse the area by gently wiping, patting or blotting. Repeat as needed.
  • for use as a moist compress – if necessary, first cleanse the area as previously described. Fold new wipe to desired size and place in contact with tissue for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed.
Generic Section

Preparation H® Medicated Wipes are made with advanced wipe technology, have been scientifically tested to be flushable and are safe for well-maintained sewer and septic systems*. They are made with 100% plant-based materials and are free from chemical binders.

*Not recommended for use with basement pump systems. Flush only one wipe at a time.

Active Ingredient (Active ingredient)

Witch hazel 50%

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

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

Questions Or Comments? (Questions or comments?)

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

Principle Display Panel

PREPARATION H

MEDICATED

HEMMORHOIDAL

WIPES


WITH WITCH HAZEL

MAXIMUM STRENGTH FORMULA

gentle, everyday cleansing to reduce irritation

WITH ALOE

  • Cools, Soothes, & Comforts
  • Convenient, Easy to Use
  • For Hemorrhoidal & Vaginal Care
  • Flushable & Septic Safe

96 WIPES

6 X 5 in. (15.2 x 12.7 cm)

2-48 COUNT POUCHES

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
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

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