Your browser does not support JavaScript! HYLATOPIC EMOLLIENT () AEROSOL, FOAM [ONSET DERMATOLOGICS LLC]
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HYLATOPIC EMOLLIENT () aerosol, foam
[Onset Dermatologics LLC]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL Premarket Notification
Drug Label Sections

For Topical Dermatological and External Use Only

Rx Only

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.

CONTRAINDICATIONS

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

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.

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.

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.

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.

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  

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

HYLATOPIC EMOLLIENT 
dressing, wound, drug aerosol, foam
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NHRIC:16781-189
Route of AdministrationTOPICALDEA Schedule    
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:16781-189-961 in 1 CARTON
1100 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK08302406/01/2009
Labeler - Onset Dermatologics LLC (793223707)
Establishment
NameAddressID/FEIBusiness Operations
Onset Dermatologics LLC793223707MANUFACTURE(16781-189)

Revised: 3/2012
 
Onset Dermatologics LLC

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