the pharma c company medicated foam with witch hazel

the pharma c company medicated foam with witch hazel
SPL v3
SPL
SPL Set ID 1a1fbe83-be45-4654-a7bb-e934e1ccd0c6
Route
topical
Published
Effective Date 2022-09-23
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 2022-05-15

Purpose

Hemorrhoidal astringent

Description

Witch hazel 50%


Medication Information

Warnings

For external use only.

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

Hemorrhoidal astringent

Directions

Adults:   

  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry area by patting or blotting with toilet tissure or a soft cloth
  • pump a small amount of foam onto clean toilet paper and apply externally to the affected area
  • after application, flush toilet paper and wash hands
  • medicated foam may be used up to 6 times daily or after each bowel movement Children under 12 years of age: ask a doctor
Other Information

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

Inactive Ingredients

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

Description

Witch hazel 50%

Drug Facts

Active Ingredient

Witch hazel 50%

Package Labeling:

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

Warnings

For external use only.

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

Hemorrhoidal astringent

Directions

Adults:   

  • when practical, clean the affected area with mild soap and warm water and rinse thoroughly
  • gently dry area by patting or blotting with toilet tissure or a soft cloth
  • pump a small amount of foam onto clean toilet paper and apply externally to the affected area
  • after application, flush toilet paper and wash hands
  • medicated foam may be used up to 6 times daily or after each bowel movement Children under 12 years of age: ask a doctor
Other Information (Other information)

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

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

Drug Facts

Active Ingredient (Active ingredient)

Witch hazel 50%

Package Labeling:

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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