Label: NANOCARE- dimethicone lotion 

  • Label RSS
  • NDC Code(s): 58466-013-13, 58466-013-18
  • Packager: Dermazone Solutions, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 10/12

If you are a consumer or patient please visit this version.

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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  • Active ingredients

    Dimethicone 1.0%

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  • Purpose

    Skin protectant

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  • Uses

    • helps prevent and relieve chafed or cracked skin
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  • 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.

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  • Directions

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

    USP water, mineral oil, petrolatum, alcohol, glyceryl stearate, PEG-100 stearate, paraffin, lecithin, polysorbate 60, DEA-cetyl phosphate, carbomer, imidazolidinyl urea, methylparaben, propylparaben, triethanolamine, essential oils

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  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Dermazone Solutions, Inc.
    2440 30th Avenue North St. Petersburg, FL 33713 USA
    Distributed by: Universal Sales & Marketing, Inc.

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  • PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label

    nanocare
    for skin

    Penetrating
    Moisturizing
    Body Lotion

    with sealing barrier

    Clinical Skin Care
    with Lyphazome® Technology

    8.0 FL OZ (236 mL)

    PRINCIPAL DISPLAY PANEL - 236 mL Bottle Label
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  • INGREDIENTS AND APPEARANCE
    NANOCARE 
    dimethicone lotion
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:58466-013
    Route of Administration TOPICAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Dimethicone (Dimethicone) Dimethicone 10 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    water  
    mineral oil  
    petrolatum  
    alcohol  
    glyceryl monostearate  
    PEG-100 stearate  
    paraffin  
    polysorbate 60  
    diethanolamine cetyl phosphate  
    imidurea  
    methylparaben  
    propylparaben  
    trolamine  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:58466-013-13 88 mL in 1 BOTTLE
    2 NDC:58466-013-18 236 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part332 11/01/2012
    Labeler - Dermazone Solutions, Inc. (136116865)
    Establishment
    Name Address ID/FEI Business Operations
    Dermazone Solutions, Inc. 136116865 MANUFACTURE(58466-013)
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