Readybath Tpc Cloth
FDA Label NDC 53329-060

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Medline Industries, Inc. for the product Readybath Tpc (NDC 53329-060). 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, do not use on, when using this product, stop use and ask a 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

Active Ingredient

Dimethicone 3.2%

Purpose

Skin Protectant

Uses

  • temporarily protects and helps relieve chapped or cracked skin
  • helps prevent perineal dermatitis
  • protects minor skin irritation associated with perineal dermatitis

Warnings

For external use only

Do Not Use On

  • deep or puncture wounds
  • animal bites
  • serious burns

When Using This Product

  • avoid direct contact with eyes
  • discontinue if irritation or redness develops

Stop Use And Ask A Doctor If

  • condition worsens
  • symptoms last more than 7 days or clear up and occur again within a few days

Keep Out Of Reach Of Children

If swallowed, get medical help or consult a Poison Control Center right away.

Directions


  • Open package as designated
  • Remove cloths and thoroughly cleanse soiled area
  • Apply as needed
  • Dispose of cloth in toilet

Other Information

Store at room temperature.

* Please review the disclaimer below.