HPRplus - MB HydroGel

Manufacturer
PruGen, Inc.
Effective date
2018-07-06
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 02:49:03

Label at a glance#

ProductHPRplus - MB HydroGel
Label structure9 sections

Dosage and administration

Dispense HPRplus TM 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.

Label contents#

Full prescribing information#

INDICATIONS FOR USE:

INDICATIONS & USAGE SECTION

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:

CONTRAINDICATIONS SECTION

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

PRECAUTIONS AND OBSERVATIONS:

PRECAUTIONS SECTION

  • 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:

INSTRUCTIONS FOR USE SECTION

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:

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 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:

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.

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

HOW SUPPLIED:

HOW SUPPLIED SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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
PRINCIPAL DISPLAY PANEL - Kit Carton

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-033-10HPRplus - MB HydroGel1 in 1 CARTONKIT12

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-030HPRPLUS - MB HYDROGEL () KIT [PRUGEN, INC.]2Unmatched20180706_9271209d-759f-4a80-ae8a-da0623f668fb.zip
42546-033HPRPLUS - MB HYDROGEL () KIT [PRUGEN, INC.]21 package rows20180706_9271209d-759f-4a80-ae8a-da0623f668fb.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-033-10EA - Each42546-0330d9b6a7f-a14f-4188-8105-08cf02270cde12015-07-20
42546-030-10GM - Gram42546-030eb9e7871-5aa6-481d-8810-48e362e42df912013-02-19
42546-030-45GM - Gram42546-03075d6f311-4a92-48fb-8e7c-80bfe29cedb212013-02-19

Products#

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

DailyMed product names page 1 of 1 · 22 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42546-03342546-033-10, 42546-033-99
42546-03042546-030-10

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 37 matching rows.

Source Document#

Source XML · Source PDF

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 3 · 59 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sterile WaterWATERREMEDYREPACK INC.5dd5d148-6e23-41de-bff5-551b2aea95982026-08-24Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58cbda7e-70c9-af85-e063-6394a90a0d172026-08-11WarningsName fallback
generic name: WATER
NINA WATER (Rich anions,Alkaline Balancing Water)WATERDMBIO.CO.,LTD.58b9b24c-7014-eb45-e063-6294a90ae4822026-08-10WarningsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC48d75a7c-8329-48a8-bea0-a8c144ddf6372026-08-07Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERCardinal Health 107, LLC9655cd02-82b5-4a75-813b-854b195514812026-07-21Warnings, Adverse reactionsName fallback
generic name: WATER
RemodulinTREPROSTINILUnited Therapeutics Corporation6c80bb38-e8db-4138-9f0d-dbbf9c6731852026-07-02Warnings, Adverse reactionsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.3a6422e1-feee-4095-8883-2b0837039e6e2026-05-07Warnings, Adverse reactionsName fallback
generic name: WATER
NINA WATER (Rich anions)WATERBIOHERB Co., Ltd.16053e79-189e-4cdf-e063-6394a90ac7762026-04-11WarningsName fallback
generic name: WATER
Sterile WaterWATERHospira, Inc.2b9ea23a-f9e9-48a8-25b7-519e3bbd68282026-03-18Warnings, Adverse reactionsName fallback
generic name: WATER
INSULIN DILUTING MEDIUM FOR KirstyWATERBiocon Biologics Inc.3db1d482-7e1f-aec6-79ef-3f305b4d82772026-01-20Warnings, Adverse reactionsName fallback
generic name: WATER
pH Neutral Emergency EyewashWATERINNOVATIVE SAFETY SUPPLY INC.29a1bd1e-d0dd-478f-e063-6394a90ab0aa2026-01-08WarningsName fallback
generic name: WATER
Quality Choice Eye WashWATERChain Drug Marketing Assoc., Inc.1fb8a109-351b-7039-e063-6394a90a73112025-12-30WarningsName fallback
generic name: WATER
OCUFRESHWATEROptics Laboratory Inc.b8e477a9-66b9-496b-92fb-3d4bbd7b36b52025-12-29WarningsName fallback
generic name: WATER
Sterile WaterWATERProPharma Distribution386a0a2f-4ff7-f128-e063-6294a90a7d4d2025-12-18Warnings, Adverse reactionsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.beda35c3-9a8b-47ad-e053-2995a90a7b1b2025-11-24WarningsName fallback
generic name: WATER
Easy Care First Aid EyewashWATERTender Corporationa070aac8-e6d2-ef10-e053-2a95a90aa5b12025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.e07a064b-f680-405c-bbcd-24fac430951e2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.777e1559-786f-8d54-e053-2991aa0aa98d2025-11-24WarningsName fallback
generic name: WATER
PUR-WASHWATERNiagara Pharmaceuticals Inc.7289103a-5cbf-42f4-8848-e827149a43ca2025-11-24WarningsName fallback
generic name: WATER
Sterile WaterWATERFresenius Kabi USA, LLCfd823bef-c14c-4708-a18a-8aaa8470412f2025-11-18Warnings, Adverse reactionsName fallback
generic name: WATER

Reported adverse events (FAERS/openFDA)#

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