HPRPLUS - MB HYDROGEL- kit

HPRplus - MB HydroGel by

Drug Labeling and Warnings

HPRplus - MB HydroGel by is a Other medication manufactured, distributed, or labeled by PruGen, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS FOR USE:

HPRplusTM 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. HPRplusTM also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS:

HPRplusTM 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.
HPRplusTM Emollient Foam:
Contents under pressure.
Do not puncture or incinerate container.
Do not expose to temperatures above 120ºF (49ºC).

PRECAUTIONS AND OBSERVATIONS:

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

DIRECTIONS - CREAM:

Dispense HPRplusTM 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.

DIRECTIONS - EMOLLIENT FOAM:

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 the 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 1-3 seconds until foam begins to dispense. If foam does not dispense within 3 seconds, prime can again.

Before Each Use:  Shake can vigorously. Firmly strike bottom of can onto palm of other hand or a hard surface at least 3 times.

During Use:  Holding can upright, dispense HPRplusTM 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, 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.

HPRplusTM Emollient Foam also contains Hydrofluorocarbon 134a (propellant).

HOW SUPPLIED:

HPRplusTM Cream is available in 100 g tubes (NDC: 42546-030-10) and 450 g jars (NDC: 42546-030-45).
HPRplusTM HydroGel is available in 225mL bottles (NDC: 42546-033-99)
HPRplusTM Emollient Foam is available in 100 g (NDC: 42546-025-10) and 150 g (NDC: 42546-025-15) canisters.
HPRplusTM Emollient Foam 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 590 and 860 F (150 and 300 C). Protect from freezing.
HPRplusTM Emollient Foam: Store upright.

Manufactured for:
PruGen, Inc. Pharmaceuticals
Scottsdale, AZ 85255
www.prugen.com
Rev 2.0

PRINCIPAL DISPLAY PANEL - Kit Carton

NDC: 42546-033-10

HPR
PLUS™
HydroGel KIT

CONVENIENCE KIT INCLUDES:
1 Bottle (225 ml) of HPRplus™ HydroGel
1 Tube (100 g) of HPRplus™ Cream

Dispense as a complete kit - Do not break up

Rx Only

PRuGEN®
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

HPRPLUS - MB HYDROGEL 
dressing, wound, drug kit

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:42546-033

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:42546-033-10	1 in 1 CARTON; Type 0: Not a Combination Product

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 TUBE	100 g
Part 2	1 BOTTLE	225 mL

Part 1 of 2

HPRPLUS 
dressing, wound, drug aerosol, foam

Product Information
Item Code (Source)	NHRIC:42546-030
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
INGR	THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
INGR	PETROLATUM (UNII: 4T6H12BN9U)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	STEARETH-10 (UNII: FD0913P475)
INGR	CETEARETH-10 PHOSPHATE (UNII: 099WOY1SA3)
INGR	HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)
INGR	NORFLURANE (UNII: DH9E53K1Y8)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:42546-030-10	1 in 1 BOX
1		100 g in 1 TUBE; Type 2: Prefilled Drug Delivery Device/System (syringe, patch, etc.)

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
PREMARKET NOTIFICATION	K113774	04/15/2015

Part 2 of 2

MB HYDROGEL 
dressing, wound, drug gel

Product Information
Item Code (Source)	NHRIC:42546-033
Route of Administration	TOPICAL

Other Ingredients
Ingredient Kind	Ingredient Name	Quantity
INGR	WATER (UNII: 059QF0KO0R)
INGR	GLYCERIN (UNII: PDC6A3C0OX)
INGR	ETHYLHEXYL PALMITATE (UNII: 2865993309)
INGR	CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
INGR	PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
INGR	DIHEXADECYL PHOSPHATE (UNII: 2V6E5WN99N)
INGR	THEOBROMA GRANDIFLORUM SEED BUTTER (UNII: I711F13FXM)
INGR	PETROLATUM (UNII: 4T6H12BN9U)
INGR	DIMETHICONE (UNII: 92RU3N3Y1O)
INGR	STEARETH-10 (UNII: FD0913P475)
INGR	CETEARETH-10 PHOSPHATE (UNII: 099WOY1SA3)
INGR	HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE (UNII: EVX7NC9YVE)
INGR	.ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)
INGR	METHYLPARABEN (UNII: A2I8C7HI9T)
INGR	EDETATE DISODIUM (UNII: 7FLD91C86K)
INGR	PROPYLPARABEN (UNII: Z8IX2SC1OH)
INGR	HYALURONATE SODIUM (UNII: YSE9PPT4TH)
INGR	SODIUM HYDROXIDE (UNII: 55X04QC32I)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:42546-033-99	225 mL in 1 BOTTLE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
PREMARKET NOTIFICATION	K113774	04/15/2015

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
PREMARKET NOTIFICATION	K113774	04/15/2015

Labeler - PruGen, Inc. (929922750)