Drug Facts

Drug Facts
SPL v3
SPL
SPL Set ID 3b1cfa8a-942f-471e-b7c0-744f83b687a0
Route
TOPICAL
Published
Effective Date 2022-07-27
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 Cocamidopropyl Betaine Cocamidopropyl Dimethylamine Diazolidinyl Urea Dichloroacetic Acid 3-dimethylaminopropylamine Glycerin Methylparaben Chloroacetic Acid Potassium Sorbate Propylene Glycol Sodium Benzoate Sodium Chloride Sodium Citrate, Unspecified Form Sodium Glycolate Water

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-08-01

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

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, cocamidopropyl betaine, cocamidopropyl dimethylamine, diazolidinyl urea, dichloroacetic, dimethylaminopropylamine, glycerin, methylparaben, monochloroacetic acid, potassium sorbate, propylene glycol, sodium benzoate, sodium chloride, sodium citrate, sodium glycolate, water

Additional Information

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.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK

©2022 GSK or licensor

Questions Or Comments?

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

Principal Display Panel

PREPARATIONH

Medicated Wipes

HEMORRHOIDAL WIPES

WITH WITCH HAZEL

gentle, everyday cleansing to reduce irritation

FLUSHABLE & SEPTIC SAFE

  • Cools, Soothes and Comforts
  • Convenient, Easy to Use
  • For Hemorrhoidal and Vaginal Care

WITH ALOE

3 60 COUNT POUCHES

180 MEDICATED WIPES

6 x 5 in. (15.2 x 12.7 cm)

000077729 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
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

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, cocamidopropyl betaine, cocamidopropyl dimethylamine, diazolidinyl urea, dichloroacetic, dimethylaminopropylamine, glycerin, methylparaben, monochloroacetic acid, potassium sorbate, propylene glycol, sodium benzoate, sodium chloride, sodium citrate, sodium glycolate, water

Additional Information (Additional information)

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.

Distributed by: GSK Consumer Healthcare, Warren, NJ 07059

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

Trademarks owned or licensed by GSK

©2022 GSK or licensor

Questions Or Comments? (Questions or comments?)

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

Principal Display Panel

PREPARATIONH

Medicated Wipes

HEMORRHOIDAL WIPES

WITH WITCH HAZEL

gentle, everyday cleansing to reduce irritation

FLUSHABLE & SEPTIC SAFE

  • Cools, Soothes and Comforts
  • Convenient, Easy to Use
  • For Hemorrhoidal and Vaginal Care

WITH ALOE

3 60 COUNT POUCHES

180 MEDICATED WIPES

6 x 5 in. (15.2 x 12.7 cm)

000077729 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
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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