AURSTAT SKIN AND WOUND HYDROGEL KIT- dressing, wound, drug   
Onset Dermatologics LLC

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INDICATIONS FOR USE

Under the supervision of a healthcare professional, HylatopicPlusTM 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. HylatopicPlusTM Cream also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

HylatopicPlusTM 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

  • HylatopicPlusTM 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 HylatopicPlusTM Cream may be continued during the anti-infective therapy.
  • If the condition does not improve within 10 – 14 days, consult a physician.
  • HylatopicPlusTM Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE

Dispense HylatopicPlusTM 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, Theobroma Grandiflorum Seed Butter, Petrolatum, Dimethicone, Steareth-10, Ceteareth-10 Phosphate, Hydroxypropyl Bispalmitamide MEA (Ceramide), Tocopheryl Acetate, Methylparaben, Disodium EDTA, Propylparaben, Sodium Hyaluronate and Sodium Hydroxide.

HOW SUPPLIED

HylatopicPlusTM 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° - 86°F (15° - 30°C).

Manufactured for:
Onset Logo

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

Patent Pending
P/N: 2623 Rev. 2 12-11

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Aurstat Skin & Wound Hydrogel Carton Label

NDC 16781-269-96

Aurstat

Skin & Wound Hydrogel

Kit

CONVENIENCE KIT INCLUDES:

1 Bottle (225mL) of Aurstat Skin & Wound HydroGel

1 Tube (100g) of HylatopicPlus Cream

HylatopicPlus

Cream

Dispense as a complete kit - Do not break up

Rx Only

Aurstat Skin & Wound Hydrogel Carton Label
                             

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - Aurstat Skin & Wound Hydrogel Label

Aurstat

Skin & Wound HydroGel

Intended for use to relieve itch and pain from minor skin irritations, lacerations, abrasions and minor burns.

225mL

 

Aurstat Skin & Wound Hydrogel Label

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - HylatopicPlus Cream 100 Gram Tube

NDC 16781-216-96

Rx Only

Net Wt 100g 

HylatopicPlus Cream 100 Gram Tube

AURSTAT SKIN AND WOUND HYDROGEL KIT 
dressing, wound, drug kit
Product Information
Product TypePRESCRIPTION MEDICAL DEVICE LABELItem Code (Source)NHRIC:16781-269
Packaging
#Item CodePackage Description
1NHRIC:16781-269-961 in 1 CARTON
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 100 g
Part 21 BOTTLE 225 mL
Part 1 of 2
HYLATOPICPLUS 
dressing, wound, drug cream
Product Information
Item 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 
INGRMETHYLPARABEN 
INGRPROPYLPARABEN 
INGRSODIUM HYDROXIDE 
INGRCETOSTEARYL ALCOHOL 
INGRDIHEXADECYL PHOSPHATE 
INGREDETATE DISODIUM 
INGRTHEOBROMA GRANDIFLORUM SEED BUTTER 
INGRHYALURONATE SODIUM 
Packaging
#Item CodePackage Description
1NHRIC:16781-216-96100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK11072708/01/2011
Part 2 of 2
AURSTAT SKIN AND WOUND HYDROGEL 
dressing, wound, drug gel
Product Information
Route of AdministrationTOPICALDEA Schedule    
Other Ingredients
Ingredient KindIngredient NameQuantity
INGRWATER 
INGRMAGNESIUM HEXAFLUOROSILICATE 
INGRSODIUM PHOSPHATE 
INGRSODIUM CHLORIDE 
INGRHYPOCHLOROUS ACID 
INGRSODIUM HYPOCHLORITE 
Packaging
#Item CodePackage Description
1225 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK09072502/01/2011
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Premarket NotificationK09072501/01/2012
Labeler - Onset Dermatologics LLC (793223707)

Revised: 04/2012
 
Onset Dermatologics LLC