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510(k) Data Aggregation

    K Number
    K122595
    Device Name
    HYDROPERMEATE TOPICAL EMULSION, ANSWER2SKIN SUNBURN RELIEF CREAM, ANSWER2SKIN FIRST AID CREAM
    Manufacturer
    Date Cleared
    2013-05-01

    (250 days)

    Product Code
    Regulation Number
    N/A
    Why did this record match?
    Applicant Name (Manufacturer) :

    DERMAL LIFE LLC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    HYDROPERMEATE™ Topical Emulsion is indicated for use in: - Full thickness wounds, pressure sores, dermal ulcers including lower leg ulcers - Superficial wounds - 1st and 2nd degree burns, including sunburns - Dermal donor and graft site management - Radiation dermatitis - Minor abrasions ANSWER2SKIN™ SUNBURN RELIEF Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor burns, including minor sunburns. ANSWER2SKIN™ FIRST AID Cream is intended to be used Over-the-Counter as a wound dressing for the following indications: minor superficial wounds and minor abrasions, including cuts and scrapes.
    Device Description
    HYDROPERMEATE™ Topical Emulsion consists of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. HYDROPERMEATE™ is a prescription product. ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are topical emulsions consisting of approximately 75% purified water, 20% wax (oily) ingredients, and 5% of dissolved ingredients such as triethanolamine sodium alginate, which forms a gel with water. ANSWER2SKIN™ SUNBURN RELIEF Cream, and ANSWER2SKIN™ FIRST AID Cream are over-the-counter products.
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