The Pharma-c Company Medicated Hemorrhoidal Pads

The Pharma-c Company Medicated Hemorrhoidal Pads
SPL v2
SPL
SPL Set ID 357703ab-4e7a-41f6-9ecf-aa98acc2d92e
Route
TOPICAL
Published
Effective Date 2022-06-16
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Witch Hazel (500 mg)
Inactive Ingredients
Aloe Vera Leaf Benzyl Alcohol Citric Acid Monohydrate Coco Glucoside Alcohol Glycerin Phenoxyethanol Potassium Sorbate Propanediol Water Sodium Citrate Tocopherol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH DRUG Active Since 2021-05-01

Description

Witch hazel (50% w/w)

Purpose

Hemorrhoidal astringent


Medication Information

Purpose

Hemorrhoidal astringent

Description

Witch hazel (50% w/w)

Uses
  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves irritation anc burning
Warnings

For external use only.

Directions
  • Adults:   
  • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • after application, discard pad and wash hands

Children under 12 years of age: ask a doctor

Drug Facts

Active Ingredient

Witch hazel (50% w/w)

Other Information

Store at a controlled room temperature: 15-30°C (59-86°F)

Package Labeling:

Inactive Ingredients

aloe barbadensis leaf juice, benzyl alcohol, citric acid, coco-glucoside, ethyl alcohol, glycerin, phenoxyethanol, potassium sorbate, propanediol, purified water, sodium citrate, tocopherol

Questions Or Comments?

1-844-308-8600

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 or vagina by using fingers or mechanical device 
Stop Use and Ask 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
  • temporarily relieves the local itching and discomfort associated with hemorrhoids
  • aids in protecting irritated anorectal areas
  • temporarily relieves irritation anc burning
Purpose

Hemorrhoidal astringent

Warnings

For external use only.

Directions
  • Adults:   
  • when practical, clean the affected area with mild soap and warm water, and rinse thoroughly
  • gently dry by patting or blotting with toilet tissue or a soft cloth before applying
  • apply externally to the affected area up to 6 times daily or after each bowel movement
  • after application, discard pad and wash hands

Children under 12 years of age: ask a doctor

Drug Facts

Active Ingredient (Active ingredient)

Witch hazel (50% w/w)

Other Information (Other information)

Store at a controlled room temperature: 15-30°C (59-86°F)

Package Labeling:

Inactive Ingredients (Inactive ingredients)

aloe barbadensis leaf juice, benzyl alcohol, citric acid, coco-glucoside, ethyl alcohol, glycerin, phenoxyethanol, potassium sorbate, propanediol, purified water, sodium citrate, tocopherol

Questions Or Comments? (Questions or comments?)

1-844-308-8600

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 or vagina by using fingers or mechanical device 
Stop Use and Ask Doctor If (Stop use and ask 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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