Topcare Medicated Wipes
FDA Label NDC 36800-330

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Topco Associates Llc for the product Topcare Medicated Wipes (NDC 36800-330). 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 otc - active ingredient, otc - purpose, warnings, otc - ask doctor, otc - do not use, otc - pregnancy or breast feeding, otc - keep out of reach of children, indications & usage, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Otc - Purpose

Uses

For temporary relief of local discomfort itching, burning, and irritation associated with hermorrhoids

Warnings

Warnings

For external use only.  Avoid contact with eyes.

Otc - Ask Doctor

Consult a doctor

  • if condition worsens or does not improve within 7 days
  • in case of bleeding
  • before exceeding the recommended dosage

Otc - Do Not Use

Do not put this product into rectum using fingers or any mechanical device or applicator.

Otc - Pregnancy Or Breast Feeding

If pregnant or breast-feeding, ask a health professional before use.

Otc - 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.

Indications & Usage

Directions

Adults and children 12 years and older- Up to 6 times daily or after each bowel movement

Children under 12- Consult a doctor

When practical, cleanse the affected area with mild soap and warm water and rinse thoroughly.

Gently dry by patting or blotting with toilet tissue or soft cloth before each application of this product. 

Gently apply to the affected area by patting and discard.  Apply to the affected area up to 6 times daily or after each bowel movement.

Storage And Handling

Store at room temperature: 15o-30oC (59o-86oF)

Inactive Ingredient

Inactive ingredients

aloe barbadensis gel, citric acid, diazolidinyl urea, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium citrate

Dosage & Administration

DISTRIBUTED BY

TOPCO ASSOCIATES LLC

7711 GROSS POINT ROAD

SKOKIE, IL 60077

QUESTIONS? 1-888-423-0139

Made in China

* Please review the disclaimer below.