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

  • NDC Code(s): 16781-189-96
  • Packager: Onset Dermatologics LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated 03/12

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, Hylatopic® 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.  Hylatopic® 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

    Hylatopic® 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

    • Hylatopic® 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 Hylatopic® Emollient Foam may be continued during the anti-infective therapy.
    • If the condition does not improve within 10-14 days, consult a physician.
    • Hylatopic® 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 well (until product moves inside can). Firmly strike bottom of can onto palm of hand at least 3 times. Hold can upright and direct initial spray to a non-skin surface. Until primed, DO NOT spray directly on the skin as the initial spray may expel cold liquid propellant.  Press down on actuator for 1-3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.

    During Use: Holding can upright, dispense Hylatopic® 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 (propellant), Glycerin, Ethylhexyl Palmitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Theobroma Grandiflorum Seed Butter, Petrolatum, Dimethicone, Steareth-10, Ceteareth-10 Phosphate, Tocopheryl Acetate, Methylparaben, Disodium EDTA, Propylparaben, Sodium Hyaluronate and Sodium Hydroxide.

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  • HOW SUPPLIED

    Hylatopic® Emollient Foam is available in 5g professional sample aluminum cans (NDC 16781-189-06) and 100g commercial aluminum cans (NDC 16781-189-96).

    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 (15º and 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: 2611-pf Rev. 5 

    Delevo Foam  

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  • PRINCIPAL DISPLAY PANEL

    PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - Hylatopic Emollient Carton Label

    NDC 16781-189-96

    Rx Only

    Hylatopic

    Emollient Foam

    Deep Dermal Hydration

    Symptom Relief for Atopic
    Dermatitis, Allergic Contact
    Dermatitis and Radiation
    Dermatitis

    Net Weight 100g

    Hylatopic Emollient Carton Label

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  • INGREDIENTS AND APPEARANCE
    HYLATOPIC EMOLLIENT 
    dressing, wound, drug aerosol, foam
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NHRIC:16781-189
    Route of Administration TOPICAL DEA Schedule     
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    ETHYLHEXYL PALMITATE  
    PROPYLENE GLYCOL  
    THEOBROMA GRANDIFLORUM SEED BUTTER  
    PETROLATUM  
    DIMETHICONE  
    STEARETH-10  
    ALPHA-TOCOPHEROL ACETATE  
    METHYLPARABEN  
    EDETATE DISODIUM  
    PROPYLPARABEN  
    SODIUM HYDROXIDE  
    CETOSTEARYL ALCOHOL  
    DIHEXADECYL PHOSPHATE  
    HYALURONATE SODIUM  
    NORFLURANE  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NHRIC:16781-189-96 1 in 1 CARTON
    1 100 g in 1 CAN
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Premarket Notification K083024 06/01/2009
    Labeler - Onset Dermatologics LLC (793223707)
    Establishment
    Name Address ID/FEI Business Operations
    Onset Dermatologics LLC 793223707 MANUFACTURE(16781-189)
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