Perineal Cooling Liners

Perineal Cooling Liners
SPL v2
SPL
SPL Set ID 88f44650-8fb7-4eb2-901d-30eb8415dc2b
Route
TOPICAL
Published
Effective Date 2022-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (500 mg)
Inactive Ingredients
Water Alcohol Sodium Benzoate Phenoxyethanol Sodium Lauroamphoacetate Benzalkonium Chloride Glycerin Benzoic Acid Citric Acid Monohydrate Peppermint Oil Menthyl Lactate, (-)- Sodium Citrate Matricaria Chamomilla Whole Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2022-10-30

Description

Witch hazel 50%

Purpose

Astringent


Medication Information

Purpose

Astringent

Description

Witch hazel 50%

Uses
  • Helps relieve pain and swelling from hemorrhoids and childbirth.
  • Temporary relief from: 
  • Irritation
  • Burning
  • Discomfort.
Warnings

For external use only.

Directions
  • remove one pad liner from pouch and place on top of maxi pad.
  • close lid after use to retain moisture.
  • replace pad liner with each maxi pad change.
Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Active Ingredient

Witch hazel 50%

Other Information
  • store at room temperature.
  • close lid after every use to retain moisture.
  • discard after every use.
  • not flushable.
Package Labeling:

Inactive Ingredients

water, alcohol, sodium benzoate, phenoxyethanol, sodium lauroamphoacetate, benzalkonium chloride, glycerin, benzoic acid, citric acid, Mentha Piperita (Peppermint) Oil, menthyl lactate, sodium citrate, Chamomilla Recutita (Matricaria) Extract, tocopherol

When Using This Product
  • avoid contact with eyes. if contact occurs, rinse thoroughly with water.
  • 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
  • rectal 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 pain and swelling from hemorrhoids and childbirth.
  • Temporary relief from: 
  • Irritation
  • Burning
  • Discomfort.
Purpose

Astringent

Warnings

For external use only.

Directions
  • remove one pad liner from pouch and place on top of maxi pad.
  • close lid after use to retain moisture.
  • replace pad liner with each maxi pad change.
Questions?

1-800-639-3803 Weekdays 9 AM to 4 PM EST

Active Ingredient (Active ingredient)

Witch hazel 50%

Other Information (Other information)
  • store at room temperature.
  • close lid after every use to retain moisture.
  • discard after every use.
  • not flushable.
Package Labeling:

Inactive Ingredients (Inactive ingredients)

water, alcohol, sodium benzoate, phenoxyethanol, sodium lauroamphoacetate, benzalkonium chloride, glycerin, benzoic acid, citric acid, Mentha Piperita (Peppermint) Oil, menthyl lactate, sodium citrate, Chamomilla Recutita (Matricaria) Extract, tocopherol

When Using This Product (When using this product)
  • avoid contact with eyes. if contact occurs, rinse thoroughly with water.
  • 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)
  • rectal 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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