Label: HYLATOPICPLUS- dressing, wound, drug cream
- NDC Code(s): 16781-216-04, 16781-216-16, 16781-216-96
- 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.
- INDICATIONS FOR USE
Under the supervision of a healthcare professional, HylatopicPlus® Cream 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® Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.Close
HylatopicPlus® Cream 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. Do not apply within four hours prior to a radiation session.Close
- PRECAUTIONS AND OBSERVATIONS
- HylatopicPlus® Cream 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® Cream may be continued during the anti-infective therapy.
- If the condition does not improve within 10-14 days, consult a physician.
- HylatopicPlus® Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.
- INSTRUCTIONS FOR USE
Dispense HylatopicPlus® Cream 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.Close
Water, 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 and Sodium Hydroxide.Close
- HOW SUPPLIED
HylatopicPlus® Cream is available in 3g professional sample tubes (NDC 16781-216-04),100g commercial tubes (NDC 16781-216-96) and 450g commercial jars (NDC 16781-216-16).
Caution: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.
Store between 59°F - 86°F (15°C - 30°C).
Cumberland, RI 02864
External Use Only
Symptom relief for atopic dermatitis, allergic contact dermatitis, and radiation dermatitis
P/N 2623 Rev. 4Close
- PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 450 Gram Jar Carton
Symptom Relief for Atopic Dermatitis,
Allergic Contact Dermatitis and Radiation Dermatitis
Net Weight 450g (15.9 oz)
- PRINCIPAL DISPLAY PANEL
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 Gram Tube Carton
Net Weight 100g
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 3 Gram Carton
Rx Only Device
Not for Sale
Net Weight 3g
- INGREDIENTS AND APPEARANCE
dressing, wound, drug cream
Product Information Product Type PRESCRIPTION MEDICAL DEVICE LABEL Item Code (Source) NHRIC:16781-216 Route of Administration TOPICAL DEA Schedule Other Ingredients Ingredient Kind Ingredient Name Quantity INGR WATER INGR GLYCERIN INGR ETHYLHEXYL PALMITATE INGR PROPYLENE GLYCOL INGR PETROLATUM INGR DIMETHICONE INGR STEARETH-10 INGR ALPHA-TOCOPHEROL ACETATE INGR PHENOXYETHANOL INGR SODIUM HYDROXIDE INGR CETOSTEARYL ALCOHOL INGR DIHEXADECYL PHOSPHATE INGR EDETATE DISODIUM INGR THEOBROMA GRANDIFLORUM SEED BUTTER INGR HYALURONATE SODIUM INGR HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:16781-216-16 1 in 1 CARTON 1 450 g in 1 JAR 2 NHRIC:16781-216-96 1 in 1 CARTON 2 100 g in 1 TUBE 3 NHRIC:16781-216-04 18 in 1 CARTON 3 3 g in 1 TUBE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Premarket Notification K110727 08/01/2011 12/31/2014 Labeler - Onset Dermatologics LLC (793223707)