Label: HYLATOPICPLUS- dressing, wound, drug cream

  • NDC Code(s): 16781-216-04, 16781-216-16, 16781-216-96
  • Packager: Onset Dermatologics LLC
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 11/14

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

  • INDICATIONS FOR USE

    Under the supervision of a healthcare professional, HylatopicPlus® Cream is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. HylatopicPlus® Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

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  • CONTRAINDICATIONS

    HylatopicPlus® Cream is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

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  • WARNINGS

    Use only as directed. Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

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  • PRECAUTIONS AND OBSERVATIONS

    • HylatopicPlus® Cream does not contain a sunscreen and should not be used prior to extended exposure to the sun.
    • If clinical signs of infection are present, appropriate treatment should be initiated; use of HylatopicPlus® Cream may be continued during the anti-infective therapy.
    • If the condition does not improve within 10-14 days, consult a physician.
    • HylatopicPlus® Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.
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  • INSTRUCTIONS FOR USE

    Dispense HylatopicPlus® Cream into palm of hand and apply to affected area 3 times per day, or as directed by a physician.Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing.

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  • INGREDIENTS

    Water, Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Petrolatum, Theobroma Grandiflorum Seed Butter, Dimethicone, Ceteareth-10 Phosphate, Steareth-10, Phenoxyethanol, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Sodium Hyaluronate, Disodium EDTA and Sodium Hydroxide.

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  • HOW SUPPLIED

    HylatopicPlus® Cream is available in 3g professional sample tubes (NDC 16781-216-04),100g commercial tubes (NDC 16781-216-96) and 450g commercial jars (NDC 16781-216-16).

    Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.

    Store between 59°F - 86°F (15°C - 30°C).

    Manufactured for:
    Onset Dermatologics
    Cumberland, RI 02864
    (888) 713-8154
    www.onsetdermatologics.com

    Onset Logo 

    Rx Only
    For Topical
    Dermatological and
    External Use Only

    HylatopicPlus Cream 

    Symptom relief for atopic dermatitis, allergic contact dermatitis, and radiation dermatitis

    P/N 2623 Rev. 4

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 450 Gram Jar Carton

    NDC 16781-216-16

    Rx Only

    HylatopicPlus Cream 

    Symptom Relief for Atopic Dermatitis,

    Allergic Contact Dermatitis and Radiation Dermatitis

    Net Weight 450g (15.9 oz) 

     

    450 g Jar Carton

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 Gram Tube Carton

    NDC 16781-216-96

    HylatopicPlus Cream

    Rx Only

    Net Weight 100g

    100 Gram Tube Carton

     

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 3 Gram Carton

    NDC 16781-216-04

    HylatopicPlus

    Cream

    Rx Only Device

    Professional Sample

    Not for Sale

    Net Weight 3g

    HylatopicPlus Cream 3g Label

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  • INGREDIENTS AND APPEARANCE
    HYLATOPICPLUS 
    dressing, wound, drug cream
    Product Information
    Product Type PRESCRIPTION MEDICAL DEVICE LABEL Item Code (Source) NHRIC:16781-216
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR GLYCERIN  
    INGR ETHYLHEXYL PALMITATE  
    INGR PROPYLENE GLYCOL  
    INGR PETROLATUM  
    INGR DIMETHICONE  
    INGR STEARETH-10  
    INGR ALPHA-TOCOPHEROL ACETATE  
    INGR PHENOXYETHANOL  
    INGR SODIUM HYDROXIDE  
    INGR CETOSTEARYL ALCOHOL  
    INGR DIHEXADECYL PHOSPHATE  
    INGR EDETATE DISODIUM  
    INGR THEOBROMA GRANDIFLORUM SEED BUTTER  
    INGR HYALURONATE SODIUM  
    INGR HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:16781-216-16 1 in 1 CARTON
    1 450 g in 1 JAR
    2 NHRIC:16781-216-96 1 in 1 CARTON
    2 100 g in 1 TUBE
    3 NHRIC:16781-216-04 18 in 1 CARTON
    3 3 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Premarket Notification K110727 08/01/2011 12/31/2014
    Labeler - Onset Dermatologics LLC (793223707)
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