Calyxra
Kit
- Prescription only
- Active substance
- Calcipotriene Cream, 0.005%
- Made by
- Florrax Pharmaceutical
- 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 · 2026-03-24
- Indicated for the treatment of plaque psoriasis.
Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.
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
- Indicated for the treatment of plaque psoriasis.
- 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 · 2026-03-24 · 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 · 2026-03-24
Do not take it if
- Do not use if known hypersensitivity to any of the listed ingredients of any of the components included on the kit.
- 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 1-2 times daily and rub in gently and completely.
- The safety and efficacy of calcipotriene cream have been demonstrated in patients treated for eight weeks.
- Once calcipotriene has been completely rubbed in completely, apply transparent dressing to the affected area as needed as a protectant.
- 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
- FOR EXTERNAL USE ONLY. Avoid contact with eyes, lips or mucous membranes.
- Contact dermatitis, including allergic contact dermatitis, has been observed with the use of calcipotriene cream.
Quoted from the official label, section “Warnings”.
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”.
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.
Quoted from the official label, section “Adverse Reactions”.
How to store it
- Calcipotriene cream, 0.005% is available in:
- NDC 68462-501-65 60 gram tube (1 tube per carton) 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 by:
- Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for:
- Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com 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.
- March 2021 glen-logo
- 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 by:
- Glenmark Pharmaceuticals Limited Colvale-Bardez, Goa 403513, India Manufactured for:
- Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430 Questions? 1 (888) 721-7115 www.glenmarkpharma-us.com 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.
- March 2021 glen-logo
Quoted from the official label, section “Storage and Handling”.
What is in it
- Calyxra DESCRIPTION Calyxra is supplied as 2 components in a kit :
- -1 TUBE OF CALCIPOTRIENE CREAM 0.005%, 60g (NDC 68462-501-65) - 30 SHEETS OF HYDROFILM TRANSPARENT DRESSING (1 BOXES OF 30 SHEETS)
- Calcipotriene cream, 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 g/mol and the following structural formula:
- Calcipotriene, USP is a white or almost white crystalline powder.
- Calcipotriene cream, 0.005% contains 50 mcg/g anhydrous calcipotriene, USP in a cream base of benzyl alcohol, cetostearyl alcohol, ceteth-20, cetostearyl alcohol, disodium hydrogen phosphate dihydrate, glycerin, medium chain triglycerides, mineral oil, monosodium phosphate monohydrate, purified water and white petrolatum. structural-formula
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.
Details
| Made by | Florrax Pharmaceutical |
|---|---|
| Active substance | Calcipotriene Cream, 0.005% |
| Form | Kit |
| Packs | 1 KIT in 1 KIT * 1 TUBE in 1 CARTON / 60 g in 1 TUBE * 10 in 1 BOX |
| NDC | 84460-803 |
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).