NIVATOPIC PLUS- dressing, wound, drug   cream 
TAGI Pharma Inc.

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NIVATOPIC
Plus
Cream

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

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.

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
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)

Revised: 1/2016
Document Id: 631aa22c-0caa-44b3-a358-460dbb48de25
Set id: b462d83d-7bf3-4327-acc0-7a95001e758f
Version: 2
Effective Time: 20160122
 
TAGI Pharma Inc.