Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID a9099cf4-4e2e-4cf1-a52f-48f8e174cb15
Route
TOPICAL
Published
Effective Date 2021-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (2 g)
Inactive Ingredients
Aloe Vera Leaf Anhydrous Citric Acid Capryl/capramidopropyl Betaine Chamomile Cucumber Diazolidinyl Urea Dipropylene Glycol Dmdm Hydantoin Edetate Disodium Glycerin Methylisothiazolinone Methylparaben Phenoxyethanol Polysorbate 20 Propylene Glycol Propylparaben Water Sodium Citrate, Unspecified Form .alpha.-tocopherol Acetate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2014-04-01

Description

Active ingredient Witch hazel 20%


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

  • open the lid on the top of the wipes pouch
  • 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
Description

Active ingredient Witch hazel 20%

Section 44425-7

Other information

  • store at 20-25°C (68-77°F)
  • for best results, flush only one or two wipes at a time
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, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, diazolidinyl urea, dipropylene glycol, DMDM hydantoin, edetate disodium, fragrance, glycerin, methylisothiazolinone, methylparaben, PEG-75 shea butter glycerides, phenoxyethanol, polysorbate 20, propylene glycol, propylparaben, purified water, sodium citrate, vitamin E acetate

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 20%

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.

Principal Display Panel

NDC 0573-0559-10

PREPARATION H ®

MEDICATED HEMORRHOIDAL WIPES

WITH WITCH HAZEL

FOR Women

FLUSHABLE & SEPTIC SAFE

infused with refreshing

CUCUMBER, SOOTHING ALOE,

VITAMIN E, SHEA BUTTER & CHAMOMILE

PreparationH ®Medicated Wipes are made with advanced 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.

PAA113382 Front Carton

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

  • open the lid on the top of the wipes pouch
  • 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
Warnings and Precautions (34071-1)

Warnings

For external use only

Section 44425-7 (44425-7)

Other information

  • store at 20-25°C (68-77°F)
  • for best results, flush only one or two wipes at a time
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, chamomilla recutita (matricaria) flower extract, cucumis sativus (cucumber) fruit extract, diazolidinyl urea, dipropylene glycol, DMDM hydantoin, edetate disodium, fragrance, glycerin, methylisothiazolinone, methylparaben, PEG-75 shea butter glycerides, phenoxyethanol, polysorbate 20, propylene glycol, propylparaben, purified water, sodium citrate, vitamin E acetate

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 20%

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.

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

NDC 0573-0559-10

PREPARATION H ®

MEDICATED HEMORRHOIDAL WIPES

WITH WITCH HAZEL

FOR Women

FLUSHABLE & SEPTIC SAFE

infused with refreshing

CUCUMBER, SOOTHING ALOE,

VITAMIN E, SHEA BUTTER & CHAMOMILE

PreparationH ®Medicated Wipes are made with advanced 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.

PAA113382 Front Carton

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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