NANOCARE (DIMETHICONE) CREAM [DERAMZONE SOLUTIONS, INC.]

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NANOCARE (DIMETHICONE) CREAM [DERAMZONE SOLUTIONS, INC.]
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NDC 58466-024-24
Set ID 064b0238-ea0b-4c3b-a032-863be27205ad
Category HUMAN OTC DRUG LABEL
Packager Deramzone Solutions, Inc.
Generic Name
Product Class
Product Number
Application Number PART332
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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredients

    Dimethicone 1.0%

  • Purpose

    Skin protectant

  • Uses

    • helps prevent and relieve chafed or cracked skin
  • Warnings

    For external use only.

    When using this product keep out of eyes.

    Do not use on

    • deep wounds
    • animal bites
    • serious burns

    Stop use and ask a doctor if

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

    Keep out of reach of children. If product is swallowed, get medical help or contact a Poison Control Center right away.

  • Directions

    • apply to dry areas as needed
    • children under 6 months: Ask a doctor
  • Inactive ingredients

    USP water, mineral oil, petrolatum, alcohol, glyceryl stearate, PEG-100 stearate, paraffin, cetyl alcohol, lecithin, essential oils, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Dermazone Solutions, Inc.
    2440 30th Avenue North St. Petersburg, FL 33713 USA

    Distributed by: Universal Sales & Marketing, Inc.

  • PRINCIPAL DISPLAY PANEL - 118 mL Jar Label

    nanocare
    for skin

    Penetrating
    Moisturizing Cream
    with sealing barrier

    4.0 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Jar Label
  • INGREDIENTS AND APPEARANCE
    NANOCARE 
    dimethicone cream
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:58466-024
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Dimethicone (UNII: 92RU3N3Y1O) (Dimethicone - UNII:92RU3N3Y1O) Dimethicone10 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    water (UNII: 059QF0KO0R)  
    mineral oil (UNII: T5L8T28FGP)  
    petrolatum (UNII: 4T6H12BN9U)  
    alcohol (UNII: 3K9958V90M)  
    glyceryl monostearate (UNII: 230OU9XXE4)  
    PEG-100 stearate (UNII: YD01N1999R)  
    paraffin (UNII: I9O0E3H2ZE)  
    cetyl alcohol (UNII: 936JST6JCN)  
    imidurea (UNII: M629807ATL)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylparaben (UNII: Z8IX2SC1OH)  
    trolamine (UNII: 9O3K93S3TK)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:58466-024-24118 mL in 1 JAR
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC MONOGRAPH NOT FINALpart33210/15/2012
    Labeler - Deramzone Solutions, Inc. (136116865)
    Establishment
    NameAddressID/FEIBusiness Operations
    Deramzone Solutions, Inc.136116865MANUFACTURE(58466-024)
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