Drug Facts

Drug Facts
SPL v6
SPL
SPL Set ID 5f122db5-4391-4957-9c25-76834c356c4f
Route
TOPICAL
Published
Effective Date 2021-01-07
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

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

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2015-12-16

Description

Witch hazel 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch hazel 50%

Uses

For temporary relief of local discomfort, burning and irritation associated with hemorrhoids

Warnings

For external use only. Avoid contact with eyes.

Directions
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product
  • Gently apply to the affected area by patting and discard
  • Apply as needed
  • For use on children under 12 years of age: consult a doctor

Do Not Use

Do not put this product into rectum using fingers or any mechanical device or applicator

Active Ingredient

Witch hazel 50%

Other Information

Store at room temperature: 15 o C - 30 o C (59 - 86 o F)

Inactive Ingredients

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

Principal Display Panel

GOOD SENSE

Pre-moistened

N 50804-047-60

Medicated Pads

Hemorrhoidal/Vaginal Pads with Witch Hazel

  • Instantly relieves hemorrhoidal burning and itching
  • Witch hazel cools, soothes and protects

Compare to the active ingredient in Tucks®* Medicated Pads*

100% SATISFACTION GURANTEED

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







Stop Use and Ask A Doctor If
  • condition worsens or does not improve within 7 days
  • in case of bleeding

Keep Out of Reach of Children.

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


Structured Label Content

Uses

For temporary relief of local discomfort, burning and irritation associated with hemorrhoids

Purpose

Astringent

Warnings

For external use only. Avoid contact with eyes.

Directions
  • When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly
  • Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product
  • Gently apply to the affected area by patting and discard
  • Apply as needed
  • For use on children under 12 years of age: consult a doctor

Do Not Use

Do not put this product into rectum using fingers or any mechanical device or applicator

Active Ingredient (Active ingredient)

Witch hazel 50%

Other Information (Other information)

Store at room temperature: 15 o C - 30 o C (59 - 86 o F)

Inactive Ingredients (Inactive ingredients)

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

Principal Display Panel

GOOD SENSE

Pre-moistened

N 50804-047-60

Medicated Pads

Hemorrhoidal/Vaginal Pads with Witch Hazel

  • Instantly relieves hemorrhoidal burning and itching
  • Witch hazel cools, soothes and protects

Compare to the active ingredient in Tucks®* Medicated Pads*

100% SATISFACTION GURANTEED

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







Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • condition worsens or does not improve within 7 days
  • in case of bleeding

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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