The Pharma C Company Medicated Foam With Witch Hazel Liquid
FDA Label NDC 55239-358

13 label sections · Submitted to the FDA by Kleen Test Products Corporation · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Kleen Test Products Corporation for the product The Pharma C Company Medicated Foam With Witch Hazel (NDC 55239-358). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient, purpose, uses, warnings, when using this product, stop use and ask doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Drug Facts

Active Ingredient

Witch hazel 50%

Purpose

Hemorrhoidal astringent

Uses

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

Warnings

For external use only.

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.

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

Questions Or Comments?

1-844-308-8600

Package Labeling:

Bottle (Bottle)

Bottle (Bottle)

* Please review the disclaimer below.