Label: PERSONAL CLEANSING WITH DIMETHICONE- dimethicone cloth

  • NDC Code(s): 63517-126-21
  • Packager: Cardinal Health 200, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None

Drug Label Information

Updated October 18, 2023

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  • Drug Facts

  • 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 
    • 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

    Warming Instructions:

  • 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

  • Package Labeling:

    Product LabelFrench Translation for Drug Facts PanelDrug Facts Panel

  • INGREDIENTS AND APPEARANCE
    PERSONAL CLEANSING WITH DIMETHICONE 
    dimethicone cloth
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63517-126
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE32 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    PPG-15 STEARYL ETHER (UNII: 1II18XLS1L)  
    GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)  
    PEG-100 STEARATE (UNII: YD01N1999R)  
    PHENOXYETHANOL (UNII: HIE492ZZ3T)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CAPRYLYL GLYCOL (UNII: 00YIU5438U)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63517-126-2142 in 1 PACKET05/15/2019
    11 in 1 POUCH
    128.59 mL in 1 PATCH; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC Monograph DrugM02205/15/2019
    Labeler - Cardinal Health 200, Inc (961027315)
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