Hemorrhoidal Treatment Wipes Cloth
FDA Label NDC 88006-050

12 label sections · Submitted to the FDA by Rootamed Llc · Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Rootamed Llc for the product Hemorrhoidal Treatment Wipes (NDC 88006-050). 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 active ingredient:, purpose:, uses:, warnings:, when using this product:, stop use and ask doctor if:, keep out of reach of of reach of children., directions:, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Active Ingredient:

Witch Hazel 50%

Purpose:

Astringent

Uses:

  • For the temporary relief of itching and discomfort associated with hemorrhoids
  • Temporary relief of irritation or burning
  • Aids in protecting irritated anorectal areas

Warnings:

For external use only

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 Doctor If:

  • Bleeding occurs
  • condition worsens or does not improve within 7 days

Keep Out Of Reach Of Of Reach Of Children.

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions:

Adult:

  • Cleanse the area by gently wiping, patting, or blotting. If necessary, repeat until all matters is removed from the area
  • use up to 6 times daily or after each bowel movement

    • Children under 12 years of age

    • consult a doctor
    • flush or dispose of wipe in trash
    • for best results, flush no more than one wipe at a time

Other Information:

Store at room temperature 20-25°C (68° - 77°F)

Inactive Ingredients:

aloe barbadensis leaf extract,citric acid,decyl glucoside, glycerin, phenoxyethanol, potassium sorbate,propylene glycol, sodium benzoate, water.

Questions:

Call 1-650-223-5410

Prinicpal Display Panel:

Simply Hazel TM

PARABEN-FREE

100% U.S.GROWN WITCH HAZEL

HEMORRHOID TREATMEMT WIPES WITCH HAZEL HEMORRHOIDAL WIPES

+ ADVACNED WINTERBLOOM BOOST

IMMEDIATE RELIEF

COOLS + SOOTHES

WITH ALOE

FLUSHABLE

20 WIPES! 5 IN. X 6 IN. (12.7 CM X 15.2 CM)

VEGAN

NO SLS

NO DYES

Simply Hazel TM Hemorrhoid Treatment Wipes are medicated extra strength US witch hazel for fast, cooling relief. Also suitable for daily cleansing of outer rectal and/or external vaginal areas.

PH-BALANCED

MAXIMUM - STRENGTH

PHYSICIAN - TESTED

PARABEN - FREE

FLUSHABLE WIPES DISPOSAL: Flush one wipe at a time.Safe for well-maintained sewer and septic systems. Not recommended for RV, marine or airplane sewage waste system.

rootamed

Distributed by RootaMed, LLC.

Post Falls, ID 83854

ww.rootamed.com

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