Label: DEODERM GEL DRESSING WITH HYALURONIC ACID-

  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Exempt device

Drug Label Information

Updated July 2, 2020

If you are a consumer or patient please visit this version.

  • DESCRIPTION

    Deoderm Gel is a soothing wound gel that is formulated for the dressing and management of superficial wounds, minor abrasions, pressure ulcers stage II - IV, 1st and 2nd degree burns, including sunburns, and radiation dermatitis. When applied properly to a wound hyaluronic acid adheres to tissue to prevent damage while supplying moisture to the cells. Medium molecular weight polysaccharides in aloe vera moisturize and reduce inflammation.  Proven therapeutic moisturizers, lipids, glycerin and allantoin, relieves dryness.

    Deoderm Gel is a non-sterile, off-white, low odor, fragrance free, topical product. The Deoderm Gel forms a physical barrier that helps to maintain a moist wound and skin environment. Deoderm Gel is a prescription medical device.

  • INDICATIONS FOR USE

    Under the supervision of a healthcare professional, Deoderm Gel is indicated to manage and relieve the burning, itching and pain experienced with various types of dermatoses, including atopic dermatitis, allergic contact dermatitis and radiation dermatitis. Deoderm Gel also helps to relieve dry, waxy skin by maintaining a moist wound and skin environment, which is beneficial to the healing process.

  • CONTRAINDICATIONS

    Deoderm Gel is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

  • WARNINGS

    Use only as directed. Keep out of the reach of children. Avoid contact with eyes. For topical use only. Not for ophthalmic use. Do not apply within four hours prior to a radiation session.

  • PRECAUTIONS AND OBSERVATIONS

    • Deoderm Gel 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 Deoderm Gel may be continued during the anti-infective therapy.
  • INSTRUCTIONS FOR USE

    Dispense Deoderm Gel into palm of hand and apply to affected area 3 times per day, or as directed by a physician. Massage gently into the skin until completely absorbed. If the skin is broken, cover with appropriate dressing Deoderm Gel is non-sterile.

  • INGREDIENTS

    Allantoin
    Aloe Barbadensis Leaf Extract
    Caprylic/Capric Triglyceride
    Carbomer
    Ceteareth 20
    Cetearyl Alcohol
    Diazolidinyl Urea & Iodopropynyl Butylcarbamate
    Dimethicone
    Glycerin
    Glycol Stearate
    Hyaluronic Acid
    Isopropyl Palmitate
    Olea Europaea (Olive) Oil
    Propylene Glycol
    Tetrasodium EDTA
    Triethanolamine
    Water

  • HOW SUPPLIED

    Deoderm Gel is available in 30g commercial pump dispenser.


    CAUTION: Federal law restricts this device to sale by or on the order of a physician or other licensed health care practitioner.


    Store between 59°F - 86°F (15°C - 30°C).

  • SPL UNCLASSIFIED SECTION

    MANUFACTURED FOR:

    Lifsa Drugs LLC
    New Brunswick, NJ 08901

  • PRINCIPAL DISPLAY PANEL

    DEODERM GEL

    NET WEIGHT: 30G

    NDC: 72336-054-01

    image description

  • INGREDIENTS AND APPEARANCE
    DEODERM  GEL DRESSING WITH HYALURONIC ACID
    dressing, wound and burn, occlusive
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:72336-054
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    OLIVE OIL (UNII: 6UYK2W1W1E)  
    MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)  
    DIMETHICONE (UNII: 92RU3N3Y1O)  
    CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)  
    POLYOXYL 20 CETOSTEARYL ETHER (UNII: YRC528SWUY)  
    HYALURONIC ACID (UNII: S270N0TRQY)  
    GLYCOL STEARATE (UNII: 0324G66D0E)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    ALLANTOIN (UNII: 344S277G0Z)  
    ISOPROPYL PALMITATE (UNII: 8CRQ2TH63M)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    DIAZOLIDINYL UREA (UNII: H5RIZ3MPW4)  
    IODOPROPYNYL BUTYLCARBAMATE (UNII: 603P14DHEB)  
    EDETATE SODIUM (UNII: MP1J8420LU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:72336-054-0130 g in 1 BOTTLE, PUMP; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    exempt deviceMDA06/12/2020
    Labeler - LIFSA DRUG LLC (081205160)