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Calsodore Cream: Package Insert / Prescribing Info

Package insert / product label
Generic name: calcipotriene, dimethicone
Dosage form: cream

Rx only

FOR TOPICAL DERMATOLOGIC USE ONLY.

Not for Ophthalmic, Oral or Intravaginal Use.

Calsodore Cream Description

Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D3 derivative, for topical dermatological use.

Chemically, calcipotriene, USP is (5Z,7E,22E,24S)-24-cyclopropyl-9,10-secochola-5,7,10(19),22-tetraene-1α,3β,24-triol, with the empirical formula C27H40O3, a molecular weight of 412.62 and the following structural formula:

structural-formula

Calcipotriene, USP is a white or almost white crystalline powder. Calcipotriene Cream USP, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum.

Calsodore Cream - Clinical Pharmacology

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 D3 (cholecalciferol) in the skin. Calcipotriene is a synthetic analog of vitamin D3.

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 D3 (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.

Clinical Studies

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.

Indications and Usage for Calsodore Cream

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.

Contraindications

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.

Warnings

Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.

Precautions

General

Use of calcipotriene cream may cause transient irritation of both lesions and surrounding uninvolved skin. If irritation develops, calcipotriene cream should be discontinued.

For external use only. Keep out of the reach of children. Always wash hands thoroughly after use.

Reversible elevation of serum calcium has occurred with use of topical calcipotriene. If elevation in serum calcium outside the normal range should occur, discontinue treatment until normal calcium levels are restored.

Information for Patients

Patients using calcipotriene cream should receive the following information and instructions:

1.
This medication is to be used only as directed by the physician. It is for external use only. Avoid contact with the face or eyes. As with any topical medication, patients should wash their hands after application.
2.
This medication should not be used for any disorder other than that for which it was prescribed.
3.
Patients should report to their physician any signs of adverse reactions.
4.
Patients that apply calcipotriene cream to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.).

Carcinogenesis, Mutagenesis, Impairment of Fertility

When calcipotriene was applied topically to mice for up to 24 months at dosages of 3, 10 and 30 mcg/kg/day (corresponding to 9, 30 and 90 mcg/m2/day), no significant changes in tumor incidence were observed when compared to control. In a study in which albino hairless mice were exposed to both UVR and topically applied calcipotriene, a reduction in the time required for UVR to induce the formation of skin tumors was observed (statistically significant in males only), suggesting that calcipotriene may enhance the effect of UVR to induce skin tumors. Patients that apply calcipotriene cream to exposed portions of the body should avoid excessive exposure to either natural or artificial sunlight (including tanning booths, sun lamps, etc.). Physicians may wish to limit or avoid use of phototherapy in patients that use calcipotriene cream.

Calcipotriene did not elicit any mutagenic effects in an Ames mutagenicity assay, a mouse lymphoma TK locus assay, a human lymphocyte chromosome aberration assay, or in a micronucleus assay conducted in mice.

Studies in rats at doses up to 54 mcg/kg/day (324 mcg/m2/day) of calcipotriene indicated no impairment of fertility or general reproductive performance.

Pregnancy

Teratogenic Effects

Studies of teratogenicity were done by the oral route where bioavailability is expected to be approximately 40 to 60% of the administered dose. Increased rabbit maternal and fetal toxicity was noted at 12 mcg/kg/day (132 mcg/m2/day). Rabbits administered 36 mcg/kg/day (396 mcg/m2/day) resulted in fetuses with a significant increase in the incidences of pubic bones, forelimb phalanges, and incomplete bone ossification. In a rat study, oral doses of 54 mcg/kg/day (318 mcg/m2/day) resulted in a significantly higher incidence of skeletal abnormalities consisting primarily of enlarged fontanelles and extra ribs. The enlarged fontanelles are most likely due to calcipotriene's effect upon calcium metabolism. The maternal and fetal calculated no-effect exposures in the rat (43.2 mcg/m2/day) and rabbit (17.6 mcg/m2/day) studies are approximately equal to the expected human systemic exposure level (18.5 mcg/m2/day) from dermal application. There are no adequate and well-controlled studies in pregnant women. Therefore, calcipotriene cream should be used during pregnancy only if the potential benefit justifies the potential risk to the fetus.

Nursing Mothers

There is evidence that maternal 1,25-dihydroxy vitamin D3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk. The systemic disposition of calcipotriene is expected to be similar to that of the naturally occurring vitamin. Because many drugs are excreted in human milk, caution should be exercised when calcipotriene cream is administered to a nursing woman.

Pediatric Use

Safety and effectiveness of calcipotriene cream in pediatric patients have not been established. Because of a higher ratio of skin surface area to body mass, pediatric patients are at greater risk than adults of systemic adverse effects when they are treated with topical medication.

Geriatric Use

Of the total number of patients in clinical studies of calcipotriene cream, approximately 15% were 65 or older, while approximately 3% were 75 and over. There were no significant differences in adverse events for subjects over 65 years compared to those under 65 years of age. However, the greater sensitivity of older individuals cannot be ruled out.

Adverse Reactions/Side Effects

Clinical Trials Experience

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 to 15% of patients. Rash, pruritus, dermatitis and worsening of psoriasis were reported in 1 to 10% of patients.

Postmarketing Experience

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.

To report SUSPECTED ADVERSE REACTIONS, contact Forreal Pharmaceuticals LLC, at 877-367-3250 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Overdosage

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).

Calsodore Cream Dosage and Administration

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.

Storage and Handling

Calcipotriene cream USP, 0.005% is available in:

60 gram tube (1 tube per carton), NDC 81877-640-60

STORAGE

Store at 20°C to 25°C (68°F to 77°F); excursions permitted to 15°C to 30°C (59°F to 86°F) [see USP Controlled Room Temperature]. Do not freeze.

Manufactured for:

Forreal Pharmaceuticals LLC, Royal Oak, MI 48067

Questions? 877-367-3250

September 2023

MEDLINE REMEDY PHYTOPLEX SKIN REPAIR- (Dimethicone 5.0%)

Drug Facts

Active ingredient

Dimethicone 5.0%

Purpose

Skin Protectant

Uses

■ Temporarily protects and helps relieve chapped or cracked skin
■ Beneficial for face, hands, body and legs.

Warnings

For external use only

Do not use on ■ deep or puncture wounds ■ animal bites ■ serious burns

When using this product
avoid contact with eyes.


Stop use and ask a doctor if

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


Keep out of reach of children.
If swallowed, get medical help or contact a Poison Control Center right away.

Directions

■ apply cream liberally as needed

Other information

■ protect from freezing ■ avoid excessive heat

Inactive ingredients

Purified Water, Cocos Nucifera (Coconut oil), Olea Europaea (Olive Oil ), Cetyl Alcohol, Glyceryl
stearate, Stearic Acid, Peg 100 stearate,Propanediol, Glycol Distearate,1,2- Hexanediol, Caprylyl
Glycol, Hydroyacetophenone, Citrus Paradisi (Grapefruit) Peel Oil, Citrus Sinensis (Orange) Peel Oil,
Citrus Reticulata (Tangerine) Peel Oil, Hexyldecanol, Bisabolol, Cetylhydroxyproline Palmitamide,
Brassica Campestris (Rapeseed) Sterols, Yeast Ferment Extract, Hydrolyzed Soy Protein, 7-
Dehydrocholestrol, Caprylic/Capric Triglcerides, Glycerin, Phospholipids, Tocopherol Acetate,
Algae Extract, Eugenia Caryophyllus (Clove) Flower Extract, Camellia Sinensis (Green Tea) Leaf
Extract, Isopropyl Myristate, Methyldihydrojasmonate, Ethylene Brassylate, Vanilla Planifolia Extract,
Carthamus Tinctorius (Safflower) Oleosomes, Manuka Honey, Cholecalciferol, Phytonadione, Jojoba
Esters, Zea Mays (Corn) Oil

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL-60 gm Carton

Forreal Pharmaceuticals LLC
YOUR SOLUTION TO BETTER HEALTHCARE

NDC: 81877-640-60
Rx ONLY

Calsodore

Kit

For Topical
Use Only

Calcipotriene Cream USP 0.005%
(1- 60 g Tube)

Occlusive Dressing
(6cm x 7 cm each, 30-Count)

Dimethicone 5% Cream
(4oz - 1 Tube)

Usual Dosage: Apply twice daily or as directed.

Keep this and all medication
out of reach of children.

See enclosed insert(s) for full prescribing information.

Storage: Store at 20° to 25°C (68° to 77°F) [see USP
Controlled Room Temperature].

Lot No:
Expiration Date:

Packaged For:
Forreal Pharmaceuticals LLC, Royal Oak, MI 48067
Question or Comments please call 877-367-3250

calsodore

CALSODORE KIT
calcipotriene, dimethicone kit
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:81877-640
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:81877-640-601 in 1 KIT09/11/2023
Quantity of Parts
Part #Package QuantityTotal Product Quantity
Part 11 TUBE 60 g
Part 21 TUBE 118 mL
Part 1 of 2
CALCIPOTRIENE
calcipotriene cream
Product Information
Item Code (Source)NDC:68462-501
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CALCIPOTRIENE (UNII: 143NQ3779B) (CALCIPOTRIENE - UNII:143NQ3779B) CALCIPOTRIENE50 ug in 1 g
Inactive Ingredients
Ingredient NameStrength
BENZYL ALCOHOL (UNII: LKG8494WBH)
CETOSTEARYL ALCOHOL (UNII: 2DMT128M1S)
CETETH-20 (UNII: I835H2IHHX)
SODIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: 94255I6E2T)
GLYCERIN (UNII: PDC6A3C0OX)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
MINERAL OIL (UNII: T5L8T28FGP)
SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE (UNII: 593YOG76RN)
WATER (UNII: 059QF0KO0R)
PETROLATUM (UNII: 4T6H12BN9U)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:68462-501-651 in 1 CARTON
160 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
ANDAANDA20577209/11/2023
Part 2 of 2
MEDLINE REMEDY PHYTOPLEX SKIN REPAIR
dimethicone cream
Product Information
Item Code (Source)NDC:53329-152
Route of AdministrationTOPICAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIMETHICONE (UNII: 92RU3N3Y1O) (DIMETHICONE - UNII:92RU3N3Y1O) DIMETHICONE5 g in 100 mL
Inactive Ingredients
Ingredient NameStrength
GELIDIELLA ACEROSA (UNII: T91K54D6M1)
METHYL DIHYDROJASMONATE (SYNTHETIC) (UNII: 3GW44CIE3Y)
HONEY (UNII: Y9H1V576FH)
ISOPROPYL MYRISTATE (UNII: 0RE8K4LNJS)
HYDROLYZED JOJOBA ESTERS (ACID FORM) (UNII: UDR641JW8W)
SACCHAROMYCES CEREVISIAE (UNII: 978D8U419H)
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S)
PHYTONADIONE (UNII: A034SE7857)
ORANGE OIL (UNII: AKN3KSD11B)
CHOLECALCIFEROL (UNII: 1C6V77QF41)
ETHYLENE BRASSYLATE (UNII: 9A87HC7ROD)
RAPESEED STEROL (UNII: B46B6DD20U)
HYDROLYZED SOY PROTEIN (ENZYMATIC; 2000 MW) (UNII: 1394NXB9L6)
CORN OIL (UNII: 8470G57WFM)
GREEN TEA LEAF (UNII: W2ZU1RY8B0)
CARTHAMUS TINCTORIUS SEED OLEOSOMES (UNII: 9S60Q72309)
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8)
PEG-100 STEARATE (UNII: YD01N1999R)
WATER (UNII: 059QF0KO0R)
STEARIC ACID (UNII: 4ELV7Z65AP)
OLIVE OIL (UNII: 6UYK2W1W1E)
COCONUT OIL (UNII: Q9L0O73W7L)
GLYCERIN (UNII: PDC6A3C0OX)
HYDROXYACETOPHENONE (UNII: G1L3HT4CMH)
CLOVE (UNII: K48IKT5321)
MANDARIN OIL (UNII: NJO720F72R)
GRAPEFRUIT OIL (UNII: YR377U58W9)
1,2-HEXANEDIOL (UNII: TR046Y3K1G)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
PROPANEDIOL (UNII: 5965N8W85T)
CETYLHYDROXYPROLINE PALMITAMIDE (UNII: 74ONU0S62G)
GLYCOL DISTEARATE (UNII: 13W7MDN21W)
CAPRYLYL GLYCOL (UNII: 00YIU5438U)
HEXYLDECANOL (UNII: 151Z7P1317)
.BETA.-BISABOLOL (UNII: LP618AV2EA)
7-DEHYDROCHOLESTEROL (UNII: BK1IU07GKF)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
VANILLIN (UNII: CHI530446X)
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:53329-152-44118 mL in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/11/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other09/11/2023
Labeler - FORREAL PHARMACEUTICALS LLC (118029197)

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