Drug Facts

Drug Facts
SPL v8
SPL
SPL Set ID 0b49db40-7abc-4e62-b6da-4b9f5b0ae16d
Route
TOPICAL
Published
Effective Date 2021-06-29
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (500 mg)
Inactive Ingredients
Water Alcohol Glycerin Phenoxyethanol Aloe Decyl Glucoside Potassium Sorbate Propylene Glycol Sodium Benzoate Citric Acid Monohydrate

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2019-02-13

Description

Witch hazel 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch hazel 50%

Uses
  • provides temporary relief of 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

adults:

  • cleane the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue prior to applying.
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • dispose of pad in thrash after use and wash hands, do not flush

children under 12 years of age: consult a doctor

Active Ingredient

Witch hazel 50%

Other Information
  • store at room temperature 15- 30 oC (59 - 86 oF)
  • for use as a moist compress - if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use.
Inactive Ingredients

Water, Alcohol, Glycerin, Phenoxyethanol, Aloe, Decyl Glucoside, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Citric Acid.

Questions Or Comments?

(800) 320-6603

Principal Display Panel

LEADER TM

NDC 70000-0364-1

Medicated Hemorrhoidal Pads

WITCH HAZEL, 50% | Astringent

Provides Immediate Relief from Itching and Burning Caused by Hemorrhoids

Witch Hazel to Soothe and Protect Irritated Areas

COMPARE TO TUCKS® MEDICATED COOLING PADS active ingredient*

100% Money Back Guarantee

100 PADS

*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark Tucks® Medicated Cooling Pads.

When Using This Product
  • do not use more than directed unless told to do so by a doctor
  • do not put directly in 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
  • provides temporary relief of 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

adults:

  • cleane the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue prior to applying.
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • dispose of pad in thrash after use and wash hands, do not flush

children under 12 years of age: consult a doctor

Active Ingredient (Active ingredient)

Witch hazel 50%

Other Information
  • store at room temperature 15- 30 oC (59 - 86 oF)
  • for use as a moist compress - if necessary, first cleanse the area and place wipe in contact with irritated area for a soothing and cooling effect. Leave in place for up to 15 minutes and repeat as needed but not to exceed directions for use.
Inactive Ingredients (Inactive ingredients)

Water, Alcohol, Glycerin, Phenoxyethanol, Aloe, Decyl Glucoside, Potassium Sorbate, Propylene Glycol, Sodium Benzoate, Citric Acid.

Questions Or Comments? (Questions or Comments?)

(800) 320-6603

Principal Display Panel

LEADER TM

NDC 70000-0364-1

Medicated Hemorrhoidal Pads

WITCH HAZEL, 50% | Astringent

Provides Immediate Relief from Itching and Burning Caused by Hemorrhoids

Witch Hazel to Soothe and Protect Irritated Areas

COMPARE TO TUCKS® MEDICATED COOLING PADS active ingredient*

100% Money Back Guarantee

100 PADS

*This product is not manufactured or distributed by McNEIL-PPC, Inc., owner of the registered trademark Tucks® Medicated Cooling Pads.

When Using This Product (When using this product)
  • do not use more than directed unless told to do so by a doctor
  • do not put directly in 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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