PRUMYX () [PRUGEN, INC.]

PRUMYX () [PRUGEN, INC.]
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NDC 42546-710-05
Set ID 85f80d40-40a9-4dbb-bdbf-1663d5cbb84a
Category PRESCRIPTION MEDICAL DEVICE LABEL
Packager PruGen, Inc.
Generic Name
Product Class
Product Number
Application Number K082089
  • DESCRIPTION

    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

    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

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

  • WARNINGS

    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

    - 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

    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

    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

    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

    NDC 42546-710-05

    PruMyx Cream

    For Topical Dermatologic Use Only

    Rx Only

    140g

    PruGen, Inc. Pharmaceuticals

    box

  • INGREDIENTS AND APPEARANCE
    PRUMYX 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:42546-710
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:42546-710-051 in 1 BOX
    1140 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK08208902/01/2009
    Labeler - PruGen, Inc. (929922750)