Label: HYLATOPICPLUS EMOLLIENT- dressing, wound, drug aerosol, foam

  • NDC Code(s): 16781-197-06, 16781-197-96, 16781-197-97
  • Packager: Onset Dermatologics LLC
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 07/13

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

  • SPL UNCLASSIFIED SECTION

    For Topical Dermatological and External Use Only

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  • INDICATIONS FOR USE

    Under the supervision of a healthcare professional, HylatopicPlus® Emollient Foam 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® Emollient Foam 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® 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. Contents under pressure. Do not puncture or incinerate container. Do not expose to temperatures above 120ºF (49ºC). Do not apply within four hours prior to a radiation session.

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  • PRECAUTIONS AND OBSERVATIONS

    • HylatopicPlus® Emollient Foam 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 Emollient Foam may be continued during the anti-infective therapy.
    • If the condition does not improve within 10-14 days, consult a physician.
    • HylatopicPlus® Emollient Foam 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

    Important: Prime Can Before Initial Use.

    To Prime Can: Shake can vigorously (until product moves inside can). Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times. Hold can upright and direct initial spray to a non-skin surface. Until foam dispenses, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant. Press down on actuator for 1 to 3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.

    During Use: Holding can upright, dispense HylatopicPlus® Emollient Foam 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. Wipe off any excess foam from actuator after use.

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  • INGREDIENTS

    Water, Hydrofluorocarbon 134a , 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, Sodium Hydroxide.

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  • HOW SUPPLIED

    HylatopicPlus® Emollient Foam is available in 5g (NDC 16781-197-06) professional sample aluminum cans and 100g (NDC 16781-197-96) and 150g (NDC 16781-197-97) commercial aluminum cans.

    Will not dispense entire contents. Container is overfilled to guarantee dispensing at least the listed amount. 

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

    Store between 59º and 86ºF (15ºC-30ºC).
    Protect from freezing.
    Store upright.

    Manufactured for:

    Onset Logo 

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

    Patent Pending         
    P/N: 2618-Rev.3 

    Delevo Foam 

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - HylatopicPlus 100g Label

    NDC 16781-197-96

    Rx Only

    HylatopicPlus

    EMOLLIENT FOAM

    Net Weight 100g

    HylatopicPlus 100g Label 

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - HylatopicPlus 150g Label

    NDC 16781-197-97

    Rx Only

    HylatopicPlus

    EMOLLIENT FOAM

    Net Weight 150g 

    HylatopicPlus 150g Label

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - HylatopicPlus 5g Label

    NDC 16781-197-06

    HylatopicPlus

    EMOLLIENT FOAM

    Rx Only

    Professional Sample

    Not for Sale

    Net Weight 5g

    Will not dispense entire contents. Container is overfilled to guarantee dispensing a minimum of 5 grams.

    HylatopicPlus 5g Label

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  • INGREDIENTS AND APPEARANCE
    HYLATOPICPLUS EMOLLIENT 
    dressing, wound, drug aerosol, foam
    Product Information
    Product Type PRESCRIPTION MEDICAL DEVICE LABEL Item Code (Source) NHRIC:16781-197
    Route of Administration TOPICAL DEA Schedule     
    Other Ingredients
    Ingredient Kind Ingredient Name Quantity
    INGR WATER  
    INGR GLYCERIN  
    INGR ETHYLHEXYL PALMITATE  
    INGR CETOSTEARYL ALCOHOL  
    INGR PROPYLENE GLYCOL  
    INGR THEOBROMA GRANDIFLORUM SEED BUTTER  
    INGR PETROLATUM  
    INGR DIMETHICONE  
    INGR STEARETH-10  
    INGR ALPHA-TOCOPHEROL ACETATE  
    INGR EDETATE DISODIUM  
    INGR PHENOXYETHANOL  
    INGR HYALURONATE SODIUM  
    INGR SODIUM HYDROXIDE  
    INGR NORFLURANE  
    INGR DIHEXADECYL PHOSPHATE  
    INGR HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:16781-197-96 1 in 1 CARTON
    1 100 g in 1 CAN
    2 NHRIC:16781-197-06 6 in 1 CARTON
    2 5 g in 1 CAN
    3 NHRIC:16781-197-97 1 in 1 CARTON
    3 150 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Premarket Notification K093051 01/01/2013
    Labeler - Onset Dermatologics LLC (793223707)
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