1. Home
  2. Labeler Index
  3. Cardinal Health 200, Inc
  4. 63517-126
  5. Label Information: Personal Cleansing With Dimethicone

FDA Label for Personal Cleansing With Dimethicone

View Indications, Usage & Precautions

Table of Contents

    1. ACTIVE INGREDIENT
    2. PURPOSE
    3. USES
    4. WARNINGS
    5. WHEN USING THIS PRODUCT
    6. STOP USE AND CONTACT A PHYSICIAN
    7. KEEP OUT OF REACH OF CHILDREN.
    8. DO NOT USE
    9. DIRECTIONS
    10. OTHER INFORMATION
    11. INACTIVE INGREDIENTS
    12. PACKAGE LABELING:

Personal Cleansing With Dimethicone Product Label

The following document was submitted to the FDA by the labeler of this product Cardinal Health 200, Inc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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


* Please review the disclaimer below.