NIVATOPIC PLUS- cream

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Available from:

TAGI Pharma Inc.

Administration route:

TOPICAL

Therapeutic indications:

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. NIVATOPIC Plus is contraindicated in persons with a known hypersensitivity to any of the components of the formulation.

Product summary:

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.

Authorization status:

Premarket Notification

Summary of Product characteristics

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
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)
a