Label: NUDERMRXPAK 60- dimethicone, calcipotriene kit

FOR TOPICAL DERMATOLOGIC USE ONLY.

Rx only

Not for Ophthalmic, Oral or Intravaginal Use.

Calcipotriene Cream, 0.005% contains calcipotriene monohydrate, a synthetic vitamin D 3 derivative, for topical dermatological use.

Chemically, calcipotriene monohydrate is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol monohydrate, with the empirical formula C 27H 40O 3•H 2O, a molecular weight of 430.6, and the following structural formula:

Calcipotriene monohydrate is a white or off-white crystalline substance. Calcipotriene Cream contains calcipotriene monohydrate equivalent to 50 μg/g anhydrous calcipotriene in a cream base of cetearyl alcohol, ceteth-20, diazolidinyl urea, dichlorobenzyl alcohol, dibasic sodium phosphate, edetate disodium, dl-alpha tocopherol, glycerin, mineral oil, petrolatum, and water.

In humans, the natural supply of vitamin D depends mainly on exposure to the ultraviolet rays of the sun for conversion of 7-dehydrocholesterol to vitamin D 3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D 3.

Clinical studies with radiolabelled calcipotriene ointment indicate that approximately 6% (± 3%, SD) of the applied dose of calcipotriene is absorbed systemically when the ointment is applied topically to psoriasis plaques, or 5% (± 2.6%, SD) when applied to normal skin, and much of the absorbed active is converted to inactive metabolites within 24 hours of application. Systemic absorption of the cream has not been studied.

Vitamin D and its metabolites are transported in the blood, bound to specific plasma proteins. The active form of the vitamin, 1,25-dihydroxy vitamin D 3 (calcitriol), is known to be recycled via the liver and excreted in the bile. Calcipotriene metabolism following systemic uptake is rapid, and occurs via a similar pathway to the natural hormone.

Adequate and well-controlled trials of patients treated with Calcipotriene Cream have demonstrated improvement usually beginning after 2 weeks of therapy. This improvement continued with approximately 50% of patients showing at least marked improvement in the signs and symptoms of psoriasis after 8 weeks of therapy, but only approximately 4% showed complete clearing.

Calcipotriene Cream, 0.005%, is indicated for the treatment of plaque psoriasis. The safety and effectiveness of topical calcipotriene in dermatoses other than psoriasis have not been established.

Calcipotriene Cream is contraindicated in those patients with a history of hypersensitivity to any of the components of the preparation. It should not be used by patients with demonstrated hypercalcemia or evidence of vitamin D toxicity. Calcipotriene Cream should not be used on the face.

Contact dermatitis, including allergic contact dermatitis, has been observed with the use of Calcipotriene Cream.

In controlled clinical trials, the most frequent adverse experiences reported for Calcipotriene Cream, 0.005% were cases of skin irritation, which occurred in approximately 10-15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.

The following adverse reactions associated with the use of Calcipotriene Cream have been identified post-approval: contact dermatitis including allergic contact dermatitis.

Topically applied calcipotriene can be absorbed in sufficient amounts to produce systemic effects. Elevated serum calcium has been observed with excessive use of topical calcipotriene. If elevation in serum calcium should occur, discontinue treatment until normal calcium levels are restored. (See PRECAUTIONS.)

Apply a thin layer of Calcipotriene Cream to the affected skin twice daily and rub in gently and completely. The safety and efficacy of Calcipotriene Cream have been demonstrated in patients treated for eight weeks.

Calcipotriene Cream, 0.005% is available in:

60 gram aluminum tubes (NDC 66993-877-61)

Store at controlled room temperature 15°C - 25°C (59°F - 77°F). Do not freeze.

Manufactured for: Prasco Laboratories, Mason, OH 45040 USA

Manufactured by: LEO Laboratories Ltd., Dublin 12, Ireland

To report SUSPECTED ADVERSE REACTIONS, contact LEO Pharma

Inc. at 1-877-494-4536 or FDA at 1-800-FDA-1088 or

www.fda.gov/medwatch

Revised 06/2017

Dimethicone 5.0%

Skin Protectant

If swallowed, get medical help or contact a Poison Control Center right away.

For the treatment and/or prevention of diaper rash.
Temporarily protects and helps relieve chapped or cracked skin.

For external use only

do not get into eyes

condition worsens

symptoms last more than 7 days or clear up and occur again within a few days

- Cleanse skin with THERATM Moisturizing Body Cleanser or THERATM Foaming Body Cleanser
- Apply cream liberally until entire area is covered
- Apply as needed

-Protect from freezing. Avoid excessive heat.

Aleurites Moluccana Seed Oil, Aloe Barbadensis (Aloe Vera) Lead Juice, SAFFLEXTM (Consisting of: Calcium Pantothenate (Vitamin B5), Maltodextrin, Niacinamide (Vitamin B3), Pyridoxine HCl (Vitamin B6), Silica, Sodium Ascorbyl Phosphate (Vitamin C), Sodium Starch Octenylsuccinate, Tocopheryl Acetate (Vitamin E)), Bisabolol, Butylene Glycol, Caprylyl Glycol, Carthamus Tinctorius (Safflower) Oleosomes, Carthamus Tintorius (Safflower) Seed Oil, Cetyl Alcohol, Chlorphenesin, Dimethicone Crosspolymer, Disodium EDTA, Glycerin, Glyceryl Stearate, Lavender Ylang Fragrance, PEG-100 Stearate, Pentaery Tetra-di-t-Butyl Hydroxyhydrocinnamate, Phenoxyethanol, Purified Water, Sodium Hyaluronate, Stearic Acid, Triethanolamine, Zingiber (Ginger) Root Extract.

NDC 66993-877-61

Calcipotriene Cream 0.005%

Net Wt. 60 g

Rx only