Label: NANOCARE- dimethicone cream

  • Category: HUMAN OTC DRUG LABEL

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 18, 2012

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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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