Calcipotriene
50 ug/g · Cream
- Prescription only
- Vitamin D Analog
- Active substance
- Calcipotriene
- Made by
- Glenmark Pharmaceuticals Inc.,USA
- Source
- Official label
Quoted from the official source. Not yet reviewed by Mediclarum — the leaflet in your pack is authoritative.
At a glance
Quoted from the official label · 2025-10-27
Vitamin D Analog
- 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.
All warnings ↓- Prescription only
- FDA enforcement reports list no ongoing recall, and none from the last two years, for this product code · checked 2026-10-02
Every line above is selected, not written, from the official label. Nothing is reworded. DailyMed
What it is for
- 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.
From the official label · 2025-10-27 · DailyMed
How it works
From this product’s own US prescribing label.
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.
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.
Quoted from the prescribing label, sections “Mechanism of Action” and “Pharmacokinetics”. DailyMed · 2025-10-27
Do not take it if
- 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.
Quoted from the official label, section “Contraindications”.
How to take it
These directions are for this exact strength and form. Another one is different.
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.
Quoted from the official label, section “Dosage & Administration”.
Other warnings
- Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
- 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.
- 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/m 2 /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.
- 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/m 2 /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.
- Nursing Mothers There is evidence that maternal 1,25-dihydroxy vitamin D 3 (calcitriol) may enter the fetal circulation, but it is not known whether it is excreted in human milk.
- Pediatric Use Safety and effectiveness of calcipotriene cream in pediatric patients have not been established.
- 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.
- 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.
Quoted from the official label, section “Warnings”.
Pregnancy and breastfeeding
- 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/m 2 /day).
- Rabbits administered 36 mcg/kg/day (396 mcg/m 2 /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/m 2 /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/m 2 /day) and rabbit (17.6 mcg/m 2 /day) studies are approximately equal to the expected human systemic exposure level (18.5 mcg/m 2 /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.
- There is evidence that maternal 1,25-dihydroxy vitamin D 3 (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.
Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.
If you take too much
In an emergency, call your local emergency number or a poison control centre.
- 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 ).
Quoted from the official label, section “Overdosage”.
Use in children
- 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.
Quoted from the official label, section “Pediatric Use”.
Use in older people
- 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.
Quoted from the official label, section “Geriatric Use”.
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 Glenmark Pharmaceuticals Inc., USA at 1 (888) 721-7115 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Quoted from the official label, section “Adverse Reactions”.
What to discuss with your doctor
- 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.).
Quoted from the official label, section “Patient Counseling Information”.
How to store it
- Calcipotriene cream USP, 0.005% is available in:
- 60 gram tube (1 tube per carton), NDC 68462-501-65 120 gram tube (1 tube per carton), NDC 68462-501-66 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.
- Distributed by:
- Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com March 2025 glenmarklogo
- 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.
- Distributed by:
- Glenmark Pharmaceuticals Inc., USA Elmwood Park, NJ 07407 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com March 2025 glenmarklogo
Quoted from the official label, section “Storage and Handling”.
What is in it
- Calcipotriene Cream USP, 0.005% contains calcipotriene, USP, a synthetic vitamin D 3 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 C 27 H 40 O 3 , a molecular weight of 412.62 and the following 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. structuralformula
Quoted from the official label, section “Description”.
Ingredients people check for
Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.
The stored label for this product has no list of inactive ingredients. The list on the pack is the one to check.
Quoted from the FDA label. A label that does not name an ingredient is not a guarantee that the product is free of it, and formulations change. With an allergy, check the pack and ask a pharmacist.
Every version of this medicine (5)
The same active substance, strength and kind of form, from every company that sells it — with what each label lists.
Showing 5 of 5
- CalcipotrieneThis onePrescription onlyGlenmark Pharmaceuticals Inc.,USANo ingredient list on the stored label
- CalcipotrienePrescription onlyGlenmark Pharmaceuticals Inc., USANo ingredient list on the stored label
- CalcipotrienePrescription onlyNorthstar Rx LLCNo ingredient list on the stored label
- CalcipotrienePrescription onlyPrasco LaboratoriesNo ingredient list on the stored label
- CalcipotrienePrescription onlyPrasco LaboratoriesNo ingredient list on the stored label
Details
| Made by | Glenmark Pharmaceuticals Inc.,USA |
|---|---|
| Active substance | Calcipotriene |
| Strength | 50 ug/g |
| Form | Cream |
| Route | Topical |
| Packs | 1 TUBE in 1 CARTON / 60 g in 1 TUBE · 1 TUBE in 1 CARTON / 120 g in 1 TUBE |
| NDC | 68462-501 |
Source: NDC Directory · 2026-09-13 · not reviewed by a clinician
Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).
Other strengths and forms
8 products are sold under this name. Grouped by form; a number on a strength means several companies make it.
- Cream3 products
50 ug/g3
50 ug/g · 3 companies
- Glenmark Pharmaceuticals Inc.,USA · this page
- Northstar Rx LLC
- Prasco Laboratories
- Ointment3 products
- .05 mg/g
50 ug/g2
50 ug/g · 2 companies
- Solution1 products
- Aerosol, Foam1 products
Same active substance
These contain the same substance. That does not mean one can replace another — ask a pharmacist.