PruClair by PruGen, Inc. PRUCLAIR-

PruClair by

Drug Labeling and Warnings

PruClair by is a Other medication manufactured, distributed, or labeled by PruGen, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

INDICATIONS & USAGE

Under the supervision of a healthcare professional, PruClair nonsteroidal cream is indicated to manage various types of dermatoses.

DIRECTIONS FOR USE:

Apply PruClair nonsteroidal cream to the affected skin areas 2 to 3 times a day (or as needed), and massage gently into the skin. If the skin is broken, cover PruClair nonsteroidal cream with a dressing of choice.

INGREDIENTS

PruClair is an off-white, nonsteroidal cream comprised of Purified water, Ethylhexyl palmitate, Pentylene glycol, Butyrospermum parkii, Glyceryl stearate, PEG-100 stearate, Arachidyl glucoside, Behenyl alcohol, Arachidyl alcohol, Bisabolol, Glycyrrhetinic acid, Carbomer, Allantoin, DMDM hydantoin, Sodium hydroxide, Disodium EDTA, Capryloyl Glycine, Vitis vinifera, Ascorbyl tetraisopalmitate, Piroctone olamine, Propyl Gallate, Ethylhexylglycerin, Sodium hyaluronate, Telmesteine, Tocopheryl Acetate, Butylene glycol.

CAUTIONS

PruClair nonsteroidal cream does not contain milk, wheat, peanut, or animal derivatives. PruClair nonsteroidal cream does contain shea butter (Butyrospermum parkii), a derivative of shea nut oil (not peanut oil). Patients with a known allergy to nuts or nut oils should consult their doctor before using this topical preparation.

Do not use the product if the packaging is damaged or after expiration date. Store at room temperature up to 25°C (77°F). Do not freeze.

OTHER PATIENT INFORMATION

The formulation contains no dyes or fragrances and is well tolerated and safe for patients of all ages. PruClair nonsteroidal cream does not contain milk, wheat or animal derivatives.

HOW SUPPLIED

100g tube (NDC: 42546-412-11)

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

PruClair Carton Label

NDC: 42546-412-11

PruClair Nonsteroidal Cream

For Topical Dermatological and External Use Only

Rx Only

100g

PruGen, Inc. Pharmaceuticals

INGREDIENTS AND APPEARANCE

PRUCLAIR 
dressing, wound, drug

Product Information
Product Type	PRESCRIPTION MEDICAL DEVICE	Item Code (Source)	NHRIC:42546-412

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:42546-412-11	1 in 1 BOX
1		100 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
premarket notification	K093156	06/01/2010

Labeler - PruGen, Inc. (929922750)