Medicated Wipes Hemorroidal Wipes With Witch Hazel

Medicated Wipes Hemorroidal Wipes With Witch Hazel
SPL v1
SPL
SPL Set ID 12441e46-5490-d45c-e063-6394a90a39e3
Route
TOPICAL
Published
Effective Date 2023-09-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (500 mg)
Inactive Ingredients
Water Dmdm Hydantoin Glycerin Benzalkonium Chloride Citric Acid Monohydrate Cocamidopropyl Betaine Aloe Vera Leaf

Identifiers & Packaging

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

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. 
  • se 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
Questions?

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

Other Information
  • for best results, flush only one wipe at a time
  • Close lid after every use to retain moisture
  • Discard after every use
  • store at room temperature 20 - 25° C (68 - 77° F)
Package Labeling:

Active Ingredients

Witch hazel 50%

Inactive Ingredients

Water, DMDM Hydantoin, Glycerin, Benzalkonium Chloride, Citric Acid, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Extract

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
  • 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 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. 
  • se 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
Questions?

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

Other Information (Other information)
  • for best results, flush only one wipe at a time
  • Close lid after every use to retain moisture
  • Discard after every use
  • store at room temperature 20 - 25° C (68 - 77° F)
Package Labeling:

Active Ingredients (Active ingredients)

Witch hazel 50%

Inactive Ingredients (Inactive ingredients)

Water, DMDM Hydantoin, Glycerin, Benzalkonium Chloride, Citric Acid, Cocamidopropyl Betaine, Aloe Barbadensis Leaf Extract

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)
  • 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.


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Raw Label Data

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