Your browser does not support JavaScript! HYLATOPICPLUS () CREAM [ONSET DERMATOLOGICS LLC]
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HYLATOPICPLUS () cream
[Onset Dermatologics LLC]


Category DEA Schedule Marketing Status
PRESCRIPTION MEDICAL DEVICE LABEL Premarket Notification
Drug Label Sections

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.

CONTRAINDICATIONS

HylatopicPlus® Cream 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. Do not apply within four hours prior to a radiation session.

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.

INGREDIENTS

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.

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).

Manufactured for:
Onset Dermatologics
Cumberland, RI 02864
(888) 713-8154
www.onsetdermatologics.com

Onset Logo 

Rx Only
For Topical
Dermatological and
External Use Only

HylatopicPlus Cream 

Symptom relief for atopic dermatitis, allergic contact dermatitis, and radiation dermatitis

P/N 2623 Rev. 4

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 450 Gram Jar Carton

NDC 16781-216-16

Rx Only

HylatopicPlus Cream 

Symptom Relief for Atopic Dermatitis,

Allergic Contact Dermatitis and Radiation Dermatitis

Net Weight 450g (15.9 oz) 

 

450 g Jar Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 100 Gram Tube Carton

NDC 16781-216-96

HylatopicPlus Cream

Rx Only

Net Weight 100g

100 Gram Tube Carton

 

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL - 3 Gram Carton

NDC 16781-216-04

HylatopicPlus

Cream

Rx Only Device

Professional Sample

Not for Sale

Net Weight 3g

HylatopicPlus Cream 3g Label

HYLATOPICPLUS 
dressing, wound, drug cream
Product Information
Product TypePRESCRIPTION MEDICAL DEVICE LABELItem Code (Source)NHRIC:16781-216
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRGLYCERIN 
INGRETHYLHEXYL PALMITATE 
INGRPROPYLENE GLYCOL 
INGRPETROLATUM 
INGRDIMETHICONE 
INGRSTEARETH-10 
INGRALPHA-TOCOPHEROL ACETATE 
INGRPHENOXYETHANOL 
INGRSODIUM HYDROXIDE 
INGRCETOSTEARYL ALCOHOL 
INGRDIHEXADECYL PHOSPHATE 
INGREDETATE DISODIUM 
INGRTHEOBROMA GRANDIFLORUM SEED BUTTER 
INGRHYALURONATE SODIUM 
INGRHYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE 
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:16781-216-161 in 1 CARTON
1450 g in 1 JAR
2NHRIC:16781-216-961 in 1 CARTON
2100 g in 1 TUBE
3NHRIC:16781-216-0418 in 1 CARTON
33 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK11072708/01/2011
Labeler - Onset Dermatologics LLC (793223707)

Revised: 4/2012
 
Onset Dermatologics LLC

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