PR Cream

Manufacturer
PruGen, Inc.
Effective date
2012-09-04
Label type
PRESCRIPTION MEDICAL DEVICE LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 02:47:36

Label at a glance#

ProductPR Cream
Label structure7 sections

Label contents#

Full prescribing information#

PRODUCT DESCRIPTION

DESCRIPTION SECTION

PR cream is a non-sterile cream formulation intended for prescription use only.

INDICATIONS & USAGE

INDICATIONS & USAGE SECTION

PR cream is indicated to manage various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and irritant contact dermatitis. PR cream helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is benefcial to the healing process.

DIRECTIONS FOR USE:

Apply a thin layer to affected areas 2-3 times per day or as directed by a physician.

INGREDIENTS

INACTIVE INGREDIENT SECTION

PR cream is a nonsteroidal cream comprised of aluminum magnesium hydroxide stearate, cetyl dimethicone copolyol, cyclomethicone, dimethicone, hexyl laurate, polyglyceryl-4-isostearate, purified water, and sodium chloride. Contains phenoxyethanol and propylparaben as preservatives.

CONTRAINDICATIONS

CONTRAINDICATIONS SECTION

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

PRECAUTIONS

PRECAUTIONS SECTION

For external use only. Avoid contact with eyes and other mucous membranes. Do not use the product if the packaging is damaged or after the expiration date. If your condition does not improve within 10-14 days, consult a physician. The safety and efficacy of PR cream has not been determined in pediatric patients.

Keep out of the reach of children.

PR cream contains no dyes or fragrances and is well tolerated and safe.

HOW SUPPLIED

HOW SUPPLIED SECTION

PR cream is available in a kit (NDC 42546-135-04) including two net wt. 2oz. (56.7g) tubes (NDC 42546-135-02) with two complimentary net wt. 2 oz. (56.7g) tubes of PruDrate® moisturizing cream.

Store at temperatures between 68° - 77°F (20° - 25°C). Do not freeze.

Manufactured for:

PruGen, Inc. Pharmaceuticals

8711 East Pinnacle Peak Road Suite C-201 P.M.B 225

Scottsdale, AZ 85255

PR Cream Box Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 42546-135-04

PR cream Nonsteroidal Cream

For Topical Dermatological Use Only

Dispense as a complete kit

Kit includes:

-2 tubes PR cream - 2oz. (56.7g)

-2 tubes PruDrate moisturizing cream - 2oz. (56.7g)

- Patient Instructions

Rx Only

PruGen, Inc. Pharmaceuticals

boxbox

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42546-135-04PR Cream56.7 g in 1 TUBE56.71
42546-135-04PR Cream2 in 1 BOX21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
42546-135PR CREAM () [PRUGEN, INC.]12 package rows20120906_5403a1f8-5432-4e47-b140-7083d65ba670.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
42546-135-04GM - Gram42546-135388fd00b-78ff-4514-826e-e870c09cda9812013-02-19

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
42546-13542546-135-04

Source Document#

Source XML

Reported adverse events (FAERS/openFDA)#

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