Label: NIVATOPIC PLUS- cream

  • NHRIC Code(s): 51224-450-20, 51224-450-10, 51224-450-01
  • Packager: TAGI Pharma Inc.
  • Category: PRESCRIPTION MEDICAL DEVICE LABEL
  • DEA Schedule: None
  • Marketing Status: Premarket Notification

Drug Label Information

Updated January 22, 2016

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

  • SPL UNCLASSIFIED SECTION

    FOR TOPICAL DERMATOLOGICAL AND EXTERNAL USE ONLY.

    Rx Only

  • INDICATIONS FOR USE

    NIVATOPIC Plus 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. NIVATOPIC Plus also helps to relieve dry, waxy skin by maintaining a moist wound & skin environment, which is beneficial to the healing process.

  • CONTRAINDICATIONS

    NIVATOPIC Plus 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

    • NIVATOPIC Plus 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 NIVATOPIC Plus may be continued during the anti-infective therapy.
    • If the condition does not improve within 10-14 days, consult a physician.
    • NIVATOPIC Plus may dissolve fuchsin when this dye is used to define the margins of the radiation fields to be treated.
  • DIRECTIONS - CREAM

    Dispense NIVATOPIC Plus Cream into palm of hand and apply to affected area three 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.

  • INGREDIENTS

    Water, Glycerin, Ethylhexyl Paimitate, Cetearyl Alcohol, Propylene Glycol, Dicetyl Phosphate, Theobroma Grandiflorum Seed Butter, Petrolatum, Dimethicone, Steareth-10, Ceteareth-10 Phosphate. Hydroxypropyl Bispalmitamide MEA (Ceramide),Tocopheryl Acetate. Methylparaben. Dlsodium EDTA, Propylparaben, Sodium Hyaluronate and Sodium Hydroxide.

  • HOW SUPPLIED

    NIVATOPIC Plus Cream is available in 100 g tubes (NDC 51224-450-10) and 450 g jars (NDC 51224-450-20)

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

    Store between 59° and 86°F (15° and 30°C). Protect from freezing.

  • SPL UNCLASSIFIED SECTION

    DISTRIBUTED BY:
    Tagi Pharma, Inc.
    722 Progressive Lane Rm 205
    South Beloit, IL 61080
    www.tagipharma.com

  • PRINCIPAL DISPLAY PANEL - 100 g Tube Label

    51224-450-10

    NIVATOPIC
    Plus

    tagiPHARMA
    That's A Good Idea

    Topical Use Only

    Rx Only
    Net Wt 100 g (3.5 oz)

    PRINCIPAL DISPLAY PANEL - 100 g Tube Label
  • INGREDIENTS AND APPEARANCE
    NIVATOPIC PLUS 
    dressing, wound, drug cream
    Product Information
    Product TypePRESCRIPTION MEDICAL DEVICEItem Code (Source)NHRIC:51224-450
    Route of AdministrationTOPICAL
    Other Ingredients
    Ingredient KindIngredient NameQuantity
    INGRwater (UNII: 059QF0KO0R)  
    INGRglycerin (UNII: PDC6A3C0OX)  
    INGRethylhexyl palmitate (UNII: 2865993309)  
    INGRcetostearyl alcohol (UNII: 2DMT128M1S)  
    INGRpropylene glycol (UNII: 6DC9Q167V3)  
    INGRdihexadecyl phosphate (UNII: 2V6E5WN99N)  
    INGRtheobroma grandiflorum seed butter (UNII: I711F13FXM)  
    INGRpetrolatum (UNII: 4T6H12BN9U)  
    INGRdimethicone (UNII: 92RU3N3Y1O)  
    INGRsteareth-10 (UNII: FD0913P475)  
    INGRceteareth-10 phosphate (UNII: 099WOY1SA3)  
    INGR.alpha.-tocopherol acetate (UNII: 9E8X80D2L0)  
    INGRmethylparaben (UNII: A2I8C7HI9T)  
    INGRedetate disodium (UNII: 7FLD91C86K)  
    INGRpropylparaben (UNII: Z8IX2SC1OH)  
    INGRhyaluronate sodium (UNII: YSE9PPT4TH)  
    INGRsodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:51224-450-204 in 1 CASE
    11 in 1 CARTON
    1450 g in 1 JAR; Type 0: Not a Combination Product
    2NHRIC:51224-450-104 in 1 CASE
    21 in 1 CARTON
    2100 g in 1 TUBE; Type 0: Not a Combination Product
    3NHRIC:51224-450-0124 in 1 CASE
    31 in 1 CARTON
    310 g in 1 TUBE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    PREMARKET NOTIFICATIONK13232906/05/2014
    Labeler - TAGI Pharma Inc. (963322560)