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
If you are a consumer or patient please visit this version.
- SPL UNCLASSIFIED SECTION
For Topical Dermatological and External Use OnlyRx Only Close
- 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.Close
HylatopicPlus® is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.Close
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.Close
- 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.Close
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.Close
- 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.
Cumberland, RI 02864
- PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - HylatopicPlus 100g Label
Net Weight 100g
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - HylatopicPlus 150g Label
Net Weight 150g
- PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - HylatopicPlus 5g Label
Not for Sale
Net Weight 5g
Will not dispense entire contents. Container is overfilled to guarantee dispensing a minimum of 5 grams.
- INGREDIENTS AND APPEARANCE
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 12/31/2014 Labeler - Onset Dermatologics LLC (793223707)