PRUCLAIR- dressing, wound, drug    
PruGen, Inc.

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PruClair Nonsteroidal Cream

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

box

PRUCLAIR 
dressing, wound, drug
Product Information
Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:42546-412
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:42546-412-111 in 1 BOX
1100 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
premarket notificationK09315606/01/2010
Labeler - PruGen, Inc. (929922750)

Revised: 9/2012
Document Id: c07f461a-5eb3-4b50-835f-15f9d1914cab
Set id: aff7b7b7-1535-40ed-aa6a-da4cba1d9107
Version: 1
Effective Time: 20120904
 
PruGen, Inc.