NOXIPAK- fluocinolone acetonide and urea kit

Riik: Ameerika Ühendriigid

keel: inglise

Allikas: NLM (National Library of Medicine)

Toimeaine:

FLUOCINOLONE ACETONIDE (UNII: 0CD5FD6S2M) (FLUOCINOLONE ACETONIDE - UNII:0CD5FD6S2M)

Saadav alates:

SOLUTECH PHARMACEUTICALS LLC

INN (Rahvusvaheline Nimetus):

FLUOCINOLONE ACETONIDE

Koostis:

FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL

Retsepti tüüp:

PRESCRIPTION DRUG

Näidustused:

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit. Fluocinolone Acetonide Topical Solution is indicated for the relief of the inflammatory and pruritic manifestations of corticosteroid-responsive dermatoses. Topical corticosteroids are contraindicated in those patients with a history of hypersensitivity to any of components of the preparation. Keratolytic For alleviating tension on the scar and its surrounding skin. Tension on a wound and scar is known to increase scar tissue formation. Because of its adherence, silicone tape reduces tension (e.g. tear and stretch) along the incision line or wound which is known to minimize the degree of scarring in terms of spreading or thickening.

Toote kokkuvõte:

Store at 20°-25°C (68° to 77°F); Keep away from heat and flame. Protect from freezing. [See USP Controlled Room Temperature.] Fluocinolone Acetonide Topical Solution 0.01%: 60 mL bottle with applicator tip - NDC 52565-012-59 Store at room temperature 15° to 25°C (59° to 77°F); avoid freezing and excessive heat above 40°C (104°F).

Volitamisolek:

New Drug Application Authorized Generic

Toote omadused

NOXIPAK- FLUOCINOLONE ACETONIDE AND UREA
SOLUTECH PHARMACEUTICALS LLC
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NOXIPAK KIT
(NDC 70350-5201-1)
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx Only
NOXIPAK KIT DESCRIPTION
NOXIPAK IS SUPPLIED AS 3 COMPONENTS IN A_ KIT_:
-
-
-
INDICATION AND USAGE
For the management of hypertrophic tissues, keloid tissues, dermatitis
and dermatoses.
1
DOSAGE AND ADMINISTRATION
First apply Fluocinolone Acetonide 0.01% Topical Solution to the
affected area, rub into skin until
absorbed. Then apply Urea 20% cream and rub into skin until completely
absorbed. Apply twice a day
or as directed by your physician. Cover the affected area with
silicone tape at bedtime or as directed by
your physician.
WARNINGS
FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous
membranes. Do not use on
areas of broken skin.
CONTRAINDICATIONS
Do not use if known hypersensitivity to any of the listed ingredients
of_ any _of the components included
on the kit.
PRECAUTIONS
Stop use and ask a doctor if redness or irritation develops. Keep this
and all other medications out of the
reach of children. If swallowed, get medical help or contact a Poison
Control Center right away.
PREGNANCY
If pregnant or breast feeding, ask a health professional before use.
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% (NDC 52565-012-59),
60mL
UREA 20% CREAM, 85g (NDC 58980-610-30), 85g
SILICONE TAPE, 1 Roll, 5.5 Yards
1
This statement has not been evaluated by the FDA. This product is not
intended to diagnose, treat, cure, or
prevent disease.
Store at 20°-25°C (68° to 77°F); Keep away from heat and flame.
Protect from freezing. [See USP
Controlled Room Temperature.]
MANUFACTURED FOR:
SOLUTECH PHARMACEUTICALS LLC
PEORIA, AZ 85345
RX ONLY
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01%
RX ONLY
DESCRIPTION
Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for
topical administration. The active
component is the corticosteroid fluocinolone acetonide, which has the
chemical name pregna-1,4-
diene-3,20-dione,6,9-difluoro-11,21-dihydrox