HPRplus – MB HydroGel: Package Insert and Label Information

HPRPLUS — MB HYDROGEL-
PruGen, Inc.

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

PRINCIPAL DISPLAY PANEL -- Kit Carton
(click image for full-size original)
HPRPLUS — MB HYDROGEL kit
Product Information
Product Type Item Code (Source) NHRIC:42546-033
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:42546-033-10 1 KIT in 1 CARTON None
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 aerosol, foam
Product Information
Item Code (Source) NHRIC:42546-030
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
ETHYLHEXYL PALMITATE
CETOSTEARYL ALCOHOL
PROPYLENE GLYCOL
DIHEXADECYL PHOSPHATE
THEOBROMA GRANDIFLORUM SEED BUTTER
PETROLATUM
DIMETHICONE
STEARETH-10
CETEARETH-10 PHOSPHATE
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE
.ALPHA.-TOCOPHEROL ACETATE
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
HYALURONATE SODIUM
SODIUM HYDROXIDE
NORFLURANE
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:42546-030-10 1 TUBE in 1 BOX contains a TUBE
1 100 g in 1 TUBE This package is contained within the BOX (42546-030-10)
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 gel
Product Information
Item Code (Source) NHRIC:42546-033
Route of Administration TOPICAL DEA Schedule
Ingredients
Ingredient Name Quantity
WATER
GLYCERIN
ETHYLHEXYL PALMITATE
CETOSTEARYL ALCOHOL
PROPYLENE GLYCOL
DIHEXADECYL PHOSPHATE
THEOBROMA GRANDIFLORUM SEED BUTTER
PETROLATUM
DIMETHICONE
STEARETH-10
CETEARETH-10 PHOSPHATE
HYDROXYPROPYL BISPALMITAMIDE MONOETHANOLAMIDE
.ALPHA.-TOCOPHEROL ACETATE
METHYLPARABEN
EDETATE DISODIUM
PROPYLPARABEN
HYALURONATE SODIUM
SODIUM HYDROXIDE
Packaging
# Item Code Package Description Multilevel Packaging
1 NHRIC:42546-033-99 225 mL in 1 BOTTLE None
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)

Revised: 07/2018 PruGen, Inc.

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