XILAPAK

(NDC 70350-5218-1)

For external use only.
Not for ophthalmic use.

Rx Only

XILAPAK is supplied as 3 components in a kit:

• -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

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

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.

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin.

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

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.

MANUFACTURED FOR:
SOLUTECH PHARMACEUTICALS LLC
PEORIA, AZ 85345

Rx Only

Fluocinolone Acetonide Topical Solution USP, 0.01%

Rx Only

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[(methylethylidene)bis(oxy)]-, (6α,11β,16α)-. It has the following chemical structure:

Chemical Structure

Fluocinolone Acetonide Solution USP contains fluocinolone acetonide 0.1 mg/mL in a water-washable base of citric acid and propylene glycol.

Topical corticosteroids share anti-inflammatory, antipruritic and vasoconstrictive actions.

The mechanism of anti-inflammatory activity of the topical corticosteroids is unclear. Various laboratory methods, including vasoconstrictor assays, are used to compare and predict potencies and/or clinical efficacies of the topical corticosteroids. There is some evidence to suggest that a recognizable correlation exists between vasoconstrictor potency and therapeutic efficacy in man.

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.

The following local adverse reactions are reported infrequently with topical corticosteroids, but may occur more frequently with the use of occlusive dressings. These reactions are listed in an approximate decreasing order of occurrence:

Topically applied corticosteroids can be absorbed in sufficient amounts to produce systemic effects (See PRECAUTIONS).

Fluocinolone Acetonide Topical Solution is generally applied to the affected area as a thin film from two to four times daily depending on the severity of the condition. In hairy sites, the hair should be parted to allow direct contact with the lesion.

Occlusive dressing may be used for the management of psoriasis or recalcitrant conditions.

If an infection develops, the use of occlusive dressings should be discontinued and appropriate antimicrobial therapy instituted.

Fluocinolone Acetonide Topical Solution 0.01%
60 mL Bottle with applicator tip - NDC 52565-012-59

Teligent Pharma, Inc.
Buena, New Jersey 08310
PI012
Iss. 11/12

Cetaphil Cleanser 4 fl oz

Galderma Laboratories, L.P.

For All Skin Types

• Mild, non-irritating formula
• Softens as it cleans
• Non-comedogenic/fragrance free
• Dermatologist recommended

This gentle, soap-free cleanser was originally formulated for dermatologists, specifically for everyday cleansing of even the most sensitive skin.

• Soothing, non-irritating cleanser ideal for face, hands and body
• Helps skin retain needed moisture
• Rinses easily and leaves skin feeling soft, smooth and healthy

Ingredients: Water, Cetyl Alcohol, Propylene Glycol, Sodium Lauryl Sulfate, Stearyl Alcohol, Methylparaben, Propylparaben, Butylparaben

Cetaphil Cleanser is easy to use:

Directions for use with water: Apply cleanser and gently massage into skin. Rinse.

Directions for use without Water: Apply a liberal amount to the skin and rub gently. Remove excess with a soft cloth, leaving a thin film of CETAPHIL on the skin.

For external use only.

Ask a doctor or pharmacist if it is safe for you to use this medicine if you have:

• Deep wounds or open sores;
• Swelling, warmth, redness, oozing, or bleeding on the site of application;
• Large areas of skin irritation;
• Any type of allergy; or
• If you are pregnant or breast-feeding.

Contraindicated in patients with known hypersensitivity to any of the listed ingredients.

No common side effects have been reported with this product. Stop use and ask a doctor if rash occurs.

Silicone Tape, 1 Roll, 5.5 yards

Silicone tape is a silicone blended tape. This tape is designed to not harm the skin when it is being removed. Most tapes pull the skin and the small hairs, causing unnecessary damage. This Silicone tape has a paper blended backing that allows a gentle, but strong adhesion to the skin that remains constant. Most tapes increase their adhesion over time, which increases the damage when they are removed.

The silicone tape can be re-positioned without losing any of its tacky qualities. The gentle adhesion does not lower the quality of the hold either. This tape is adhesive enough that it can be worn in the shower without losing effectiveness.

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.

FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes. Do not use on areas of broken skin. Do not use if you have known hypersensitivity to silicone

Stop use and ask a doctor if redness or irritation or rash develops. Keep out of reach of children.

Apply to the affected area as directed by your physician.

Solutech
PHARMACEUTICALS

XILAPAK KIT

NDC 70350-5218-1

RX ONLY