Personal Cleansing With Dimethicone Cloth
FDA Label NDC 63517-126

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cardinal Health 200, Inc for the product Personal Cleansing With Dimethicone (NDC 63517-126). 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 contact a physician, keep out of reach of children., do not use, 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

When Using This Product

  • Avoid direct contact with the eyes

Stop Use And Contact A Physician

  • 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 contact Posion Control Center right away.

  • Discontinue if irritation or redness develops
  • Gloves diminish sensitivity to heat
  • Closely monitor heat level with infants, unresponsive or skin sensitive individuals

Do Not Use

  • On deep or puncture wounds
  • Animal bites
  • Serious burns

Directions

  • Pull back label and remove wipes
  • Thoroughly cleanse soiled area, using one wipe at a time
  • Use as often as necessary
  • Dispose of cloths in a waste receptacle
  • Do not flush 

    • Warming Instructions:

    • Wipes may be used at room temperature but if heating is desired, wipes may be warmed in a wipes warmer. Wipes should be warmed:
    • In a single warming session at temperatures not exceeding 52°C (125°F) and 
    • for a maximum of 200 hours. Discard wipes that have been:
    • Exposed to warming temperatures exceeding 52°C (125°F); or 
    • Stored longer than 200 hours within the warmer; or
    • Been warmed, allowed to cool, and then re-warmed

Other Information

When not in a warmer, store between 15-30˚C (59-86˚F).

Inactive Ingredients

Aqua, Glycerin, PPG-15 Stearyl Ether, Glyceryl Stearate, PEG-100 Stearate, Phenoxyethanol, Aloe Barbadensis Leaf Extract, Caprylyl Glycol, Cetearyl Alcohol, Xanthan Gum

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