PRUCLAIR () [PRUGEN, INC.]

PRUCLAIR () [PRUGEN, INC.]
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NDC 42546-412-11
Set ID aff7b7b7-1535-40ed-aa6a-da4cba1d9107
Category PRESCRIPTION MEDICAL DEVICE LABEL
Packager PruGen, Inc.
Generic Name
Product Class
Product Number
Application Number K093156
  • 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

  • INGREDIENTS AND APPEARANCE
    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)