HPRplus - MB HydroGel Kit

Manufacturer
PruGen, Inc.
Effective date
2013-05-13
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:41

Label at a glance#

ProductHPRplus - MB HydroGel Kit
Label structure9 sections

Dosage and administration

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 ...

Label contents#

Full prescribing information#

INDICATIONS FOR USE

INDICATIONS & USAGE SECTION

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

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

HPRplus is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

WARNINGS

WARNINGS SECTION

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.

HPRplus Emollient Foam:

Contents under pressure.

Do not puncture or incinerate container.

Do not expose to temperatures above 120o F (49oC)

PRECAUTIONS AND OBSERVATIONS

PRECAUTIONS SECTION

• HPRplus 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 HPRplus may be continued during the anti-infective therapy.

• If the condition does not improve within 10-14 days, consult a physician.

• HPRplus may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

DIRECTIONS-EMOLLIENT FOAM

INSTRUCTIONS FOR USE SECTION

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 HPRplus 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

INACTIVE INGREDIENT SECTION

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

HOW SUPPLIED

HOW SUPPLIED SECTION

HPRplus 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 59o and 86oF (15o and 30oC). Protect from freezing.

HPRplus Emollient Foam: Store upright. 

Manufactured for:
PruGen, Inc. Pharmaceuticals 
8714 E Vista Bonita Dr
Scottsdale, AZ 85255
www.prugen.com

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - HPRplus - MB HydroGel Kit Carton Label

NDC  42546-026-10

HPRplus - MB HydroGel Kit

CONVENIENCE KIT INCLUDES:

1 Canister (100g) of HPRplus Emollient Foam

1 Bottle (225g) of MB HydroGel

Dispense as a complete kit - Do not break up

Rx Only

boxbox

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - MB HydroGel Label

MB HydroGel

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

225g

hydrogellabelhydrogellabel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

PACKAGE LABEL - PRINCIPAL DISPLAY PANEL - HPRplus Emollient Foam 100 Gram Canister

NDC 42546-025-10

Rx Only

Net Wt 100g 

foamlabelfoamlabel

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-026-10HPRplus - MB HydroGel Kit1 in 1 CARTONKIT11

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-025HPRPLUS - MB HYDROGEL KIT () KIT [PRUGEN, INC.]1Unmatched20130516_fa6dc9b3-2971-464f-ab3a-c2cae1243fbb.zip
42546-026HPRPLUS - MB HYDROGEL KIT () KIT [PRUGEN, INC.]11 package rows20130516_fa6dc9b3-2971-464f-ab3a-c2cae1243fbb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-026-10GM - Gram42546-026d618c957-63d9-4fb9-9170-3737a35cafd512013-07-02
42546-025-10GM - Gram42546-02573ec323c-4919-4fa3-a74d-a331a38c6a8612013-02-19
42546-025-15GM - Gram42546-025dbf56df2-2e6b-441b-8f86-55cb1c8ac9da12013-02-19

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 2 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42546-02642546-026-10
42546-02542546-025-10

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.