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