PruMyx External Cream

Manufacturer
PruGen, Inc.
Effective date
2012-08-22
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:35

Label at a glance#

ProductPruMyx
Label structure9 sections

Label contents#

Full prescribing information#

DESCRIPTION

DESCRIPTION SECTION

PruMyx Cream is a fragrance free, preservative free, water-based emulsion formulated for the management and relief of the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. PruMyx Cream helps to relieve the dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

PruMyx Cream is indicated to manage and relieve the burning and itching experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. PruMyx Cream helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

WARNINGS

WARNINGS SECTION

In radiation therapy, PruMyx Cream may be applied as indicated by the treating Radiation Oncologist. Do not apply 4 hours prior to a radiation session.

PRECAUTIONS AND OBSERVATIONS

PRECAUTIONS SECTION

- PruMyx Cream is for external use only.

- PruMyx 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 PruMyx Cream may be continued during the anti-infective therapy.

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

- Keep this and other similar products out of the reach of children.

- PruMyx Cream may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.

INSTRUCTIONS FOR USE

INSTRUCTIONS FOR USE SECTION

Apply PruMyx Cream to the affected skin areas 3 times per day (or as needed), and massage gently into the skin. If the skin is broken, cover PruMyx Cream with a dressing of choice.

INGREDIENTS

INACTIVE INGREDIENT SECTION

PruMyx Cream contains purified water, olive oil, glycerin, pentylene glycol, palm glycerides, vegetable oil, hydrogenated lecithin, squalane, betaine, palmitamide MEA, sarcosine, acetamide MEA, hydroxyethyl cellulose, sodium carbomer, carbomer, xanthan gum.

HOW SUPPLIED

HOW SUPPLIED SECTION

PruMyx Cream is available in a 140 gram tube, NDC 42546-710-05.

Store at 15ºC to 30ºC (59ºF to 86ºF). Do not freeze.

PruGen, Inc. Pharmaceuticals

8711 East Pinnacle Peak Road

Suite C-201 P.M.B.225

Scottsdale, AZ 85255

PruMyx Carton Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42546-710-05

PruMyx Cream

For Topical Dermatologic Use Only

Rx Only

140g

PruGen, Inc. Pharmaceuticals

boxbox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-710-05PruMyx1 in 1 BOX11
42546-710-05PruMyx140 g in 1 TUBE1401

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-710PRUMYX () [PRUGEN, INC.]12 package rows20120829_85f80d40-40a9-4dbb-bdbf-1663d5cbb84a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-710-05GM - Gram42546-71036e1bc86-6ca7-4602-bac2-6de60d33de1c12013-02-19

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
42546-71042546-710-05

Source Document#

Source XML · Source PDF

Reported adverse events (FAERS/openFDA)#

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