SUVICORT RX SKIN EMULSION () [STERLING-KNIGHT PHARMACEUTICALS, LLC]

SUVICORT RX SKIN EMULSION () [STERLING-KNIGHT PHARMACEUTICALS, LLC]
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NDC 69336-808-28, 69336-808-30, 69336-808-60
Set ID ae3989ee-7826-4d25-9df6-278f0469de1e
Category PRESCRIPTION MEDICAL DEVICE LABEL
Packager Sterling-Knight Pharmaceuticals, LLC
Generic Name
Product Class
Product Number
Application Number K020540
  • DESCRIPTION

    Suvicort Rx Emulsion is a soothing wound gel that promotes a moist wound environment that is ideal for the healing process.

  • INDICATIONS & USAGE

    Suvicort Rx Skin Emulsion is indicated as a prescription topical skin care emulsion for the management of painful wounds. Suvicort Rx Skin Emulsion helps maintain a moist wound and skin environment, which is beneficial to the healing process.

    Directions: Apply a small amount of Suvicort Rx Emulsion in sufficient quantity to cover the affected skin area to be protected, and allow to dry. Reapply up to 4 times per day (or as needed).

  • WARNINGS

    External use only. Do not use this product if you are allergic to any of the ingredients. Avoid contact with eyes. Sterile unless opened or damaged.

  • PRECAUTIONS:

    Federal law restricts this device to sale by or on the order of a licensed healthcare practitioner.

    CALL YOUR DOCTOR ABOUT SIDE EFFECTS.
    Call your doctor about side effects. You may report side effects to Sterling Knight Pharmaceuticals, LLC at 1-888-460-1531 or the FDA at 1-800-FDA-1088.

  • INSTRUCTIONS FOR USE

    Apply a small amount of Suvicort Rx Emulsion in sufficient quantity to cover the affected skin area to be protected, and allow to dry. Reapply up to 4 times per day (or as needed).

  • INGREDIENTS

    Water, Collagen, Aloe Vera gel, Lidocaine Hydrochloride, Sodium alginate, Glycerin, Hydroxyethylcellulose, Triethanolamine, Benzethonium chloride.

  • HOW SUPPLIED

    Suvicort Rx Emulsion is supplied in:

    60g tube, NDC 69336-808-60

    30g tube, NDC 69336-808-30


    28g tube, NDC 69336-808-28

    Distributed By:
    Sterling-Knight Pharmaceuticals, LLC
    Ripley, MS 38663
    Rev 092018-1

  • STORAGE:

    Store at 25°C (77°F): excursions permitted to 15°-30°C (59°-86°F). Protect from freezing [See USP Controlled Room Temperature].

  • PRINCIPAL DISPLAY PANEL

    label1

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    label3

    label4label5

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  • INGREDIENTS AND APPEARANCE
    SUVICORT RX SKIN EMULSION 
    dressing, wound, drug
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:69336-808
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:69336-808-6060 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    2NHRIC:69336-808-3030 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    3NHRIC:69336-808-2828 g in 1 TUBE; Type 9: Other Type of Part 3 Combination Product (e.g., Drug/Device/Biological Product)
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    premarket notificationK02054009/17/2018
    Labeler - Sterling-Knight Pharmaceuticals, LLC (079556942)

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