Noxipak

Generic name: fluocinolone acetonide and urea
Dosage form: 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:

-

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

INDICATION AND USAGE

For the management of hypertrophic tissues, keloid tissues, dermatitis and dermatoses. 1

1

This statement has not been evaluated by the FDA. This product is not intended to diagnose, treat, cure, or prevent disease.

Noxipak 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.

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

Noxipak Description

Fluocinolone Acetonide Topical Solution USP, 0.01% is intended for topical administration. The active component is the corticoster