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


Category DEA Schedule Marketing Status
PRESCRIPTION MEDICAL DEVICE 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, 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.

CONTRAINDICATIONS

HylatopicPlus® 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

  • 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.

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.

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.

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 

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

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

HYLATOPICPLUS EMOLLIENT 
dressing, wound, drug aerosol, foam
Product Information
Product TypePRESCRIPTION MEDICAL DEVICE LABELItem Code (Source)NHRIC:16781-197
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRGLYCERIN 
INGRETHYLHEXYL PALMITATE 
INGRCETOSTEARYL ALCOHOL 
INGRPROPYLENE GLYCOL 
INGRTHEOBROMA GRANDIFLORUM SEED BUTTER 
INGRPETROLATUM 
INGRDIMETHICONE 
INGRSTEARETH-10 
INGRALPHA-TOCOPHEROL ACETATE 
INGREDETATE DISODIUM 
INGRPHENOXYETHANOL 
INGRHYALURONATE SODIUM 
INGRSODIUM HYDROXIDE 
INGRNORFLURANE 
INGRDIHEXADECYL PHOSPHATE 
INGRHYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:16781-197-961 in 1 CARTON
1100 g in 1 CAN
2NHRIC:16781-197-066 in 1 CARTON
25 g in 1 CAN
3NHRIC:16781-197-971 in 1 CARTON
3150 g in 1 CAN
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK09305101/01/2013
Labeler - Onset Dermatologics LLC (793223707)

Revised: 7/2013
 
Onset Dermatologics LLC

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