SPL v3
SPL
SPL Set ID 0f28d5f9-b20a-ac6f-e063-6394a90ac208
Route
TOPICAL
Published
Effective Date 2024-01-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (50 mg)
Inactive Ingredients
Propylene Glycol Sodium Benzoate Phenoxyethanol Water Aloe Vera Leaf Citric Acid Monohydrate Decyl Glucoside Glycerin Potassium Sorbate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2024-01-17

Description

Witch Hazel 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch Hazel 50%

Uses

helps relieve the local itching and discomfort associated with hemmorhoids

temporary relief of irritation and burning

aids in protecting irritated anorectal areas

Warnings

For external use only

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 upto 6 times daily or after each bowel movement and before applying hemorrhoidal treatments and then discard.
  • children under 12 years of age consult a doctor
  • flush or dispose of wipe in trash
    • for best results flush no more than one wipe at a time
Questions?

Call 1-718-975-2586

Active Ingredient

Witch Hazel 50%

Other Information
  • store at room temperature 20-25ºC (68-77ºF)
  • for vaginal care - cleanse the area by gently wiping, patting or blotting. Repeat as needed.
  • for use as moist compress if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing or cooling effect. Leave in place for 15 minutes and repeat as needed.
Inactive Ingredients

Aloe Barbadensis (Aloe) Leaf Extract, Citric Acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water

Principal Display Panel

NDC 78691-050-15

Biopure

Medicated Multipurpose Wipes With Witch Hazel

relieves hemorrhoids, poison ivy, acne and more

MADE WITH ALOE COOLS & SOOTHES

Made in U.S.A. with globally sourced materials

5 in X 6 in (12.70 cm X 15.24 cm)

15 WIPES

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 Poison Control Center right away. (1-800-222-1222)


Structured Label Content

Uses

helps relieve the local itching and discomfort associated with hemmorhoids

temporary relief of irritation and burning

aids in protecting irritated anorectal areas

Purpose

Astringent

Warnings

For external use only

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 upto 6 times daily or after each bowel movement and before applying hemorrhoidal treatments and then discard.
  • children under 12 years of age consult a doctor
  • flush or dispose of wipe in trash
    • for best results flush no more than one wipe at a time
Questions?

Call 1-718-975-2586

Active Ingredient

Witch Hazel 50%

Other Information
  • store at room temperature 20-25ºC (68-77ºF)
  • for vaginal care - cleanse the area by gently wiping, patting or blotting. Repeat as needed.
  • for use as moist compress if necessary, first cleanse the area as previously described. Fold wipe to desired size and place in contact with tissue for a soothing or cooling effect. Leave in place for 15 minutes and repeat as needed.
Inactive Ingredients

Aloe Barbadensis (Aloe) Leaf Extract, Citric Acid, Decyl Glucoside, Glycerin, Phenoxyethanol, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Water

Principal Display Panel

NDC 78691-050-15

Biopure

Medicated Multipurpose Wipes With Witch Hazel

relieves hemorrhoids, poison ivy, acne and more

MADE WITH ALOE COOLS & SOOTHES

Made in U.S.A. with globally sourced materials

5 in X 6 in (12.70 cm X 15.24 cm)

15 WIPES

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 Poison Control Center right away. (1-800-222-1222)


Advanced Ingredient Data


Raw Label Data

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