XILAPAK- fluocinolone acetonide kit

Država: Združene države Amerike

Jezik: angleščina

Source: NLM (National Library of Medicine)

Aktivna sestavina:

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

Dostopno od:

SOLUTECH PHARMACEUTICALS LLC

INN (mednarodno ime):

FLUOCINOLONE ACETONIDE

Sestava:

FLUOCINOLONE ACETONIDE 0.1 mg in 1 mL

Tip zastaranja:

PRESCRIPTION DRUG

Terapevtske indikacije:

Do not use if known hypersensitivity to any of the listed ingredients of any of the components included in 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. Contraindicated in patients with known hypersensitivity to any of the listed ingredients. 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.

Povzetek izdelek:

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).

Status dovoljenje:

New Drug Application Authorized Generic

Lastnosti izdelka

XILAPAK- FLUOCINOLONE ACETONIDE
SOLUTECH PHARMACEUTICALS LLC
----------
XILAPAK KIT
(NDC 70350-5218-1)
FOR EXTERNAL USE ONLY.
NOT FOR OPHTHALMIC USE.
Rx Only
XILAPAK KIT DESCRIPTION
XILAPAK 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
Apply Cetaphil Cleanser to the affected area, rub gently and rinse
with water. Then apply Fluocinolone
Acetonide 0.01% Topical Solution and rub into skin until 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
in the kit.
PRECAUTIONS
Stop use and ask a doctor if redness or irritation develops. Keep this
and all other medications out of
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.
Store at 20°-25°C (68° to 77°F); Keep away from heat and flame.
Protect from freezing. [See USP
FLUOCINOLONE ACETONIDE TOPICAL SOLUTION USP, 0.01% (NDC 52565-012-59),
60mL
CETAPHIL CLEANSER (NDC 00299-3921-40), 4 fl oz
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.
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-dihydroxy16,17[(methylethylid