ACTIKERALL 10 % — DIN 02428946
SALICYLIC ACID : 10 % FLUOROURACIL : 0.5 % · CIPHER PHARMACEUTICALS INC · SOLUTION · wholesale supply in Canada
Health Canada status: MARKETED
What is ACTIKERALL?
ACTIKERALL 10 % contains SALICYLIC ACID : 10 % FLUOROURACIL : 0.5 %. It is listed in the Health Canada Drug Product Database under DIN 02428946, held by CIPHER PHARMACEUTICALS INC, supplied as SOLUTION for TOPICAL administration. Health Canada currently lists it as marketed, status dated 19-Feb-2016. Nexara Health is a licensed Canadian wholesale distributor (DEL 3-002896-A) and can source this product for hospitals, pharmacies and clinics. Availability and lead time are confirmed per order.
What is ACTIKERALL used for?
ACTIKERALL (fluorouracil and salicylic acid) is indicated for the topical treatment of slightly palpable and/or moderately thick hyperkeratotic actinic keratosis (Grade I/II) of the face, forehead, and balding scalp in immunocompetent adult patients. Grade I/II intensity is based on the 4-point scale of Olsen et al (see CLINICAL TRIALS).
Authorized indication as written in the Health Canada product monograph. For healthcare professionals and licensed purchasers; this is not medical advice.
How is it supplied and stored?
Pack configuration, storage class and the handling constraints that drive cold-chain planning. One DIN can cover more than one pack size, and the pack — not the DIN — is what gets priced, shipped and invoiced.
| Strength on the label | 10 % |
|---|---|
| Dosage form | SOLUTION |
| Route | TOPICAL |
| Pack configuration (monograph) | null |
| Storage | Store between 15 to 25°C. Do not refrigerate or freeze. The bottle should be closed tightly after use or the solution will dry up quickly and can no longer be used correctly. The solution should not be used if crystals occur. Use within 3 months of opening. Keep out of the reach of children. |
| Shipping class | Cold chain — validated shipper with temperature monitoring |
Before an order line is unambiguous Nexara needs the strength, the pack size and the presentation.
Cold chain. This product is stored refrigerated. Nexara ships it on a validated cold chain with temperature monitoring; a delivery address that cannot receive and store it at 2–8 °C on arrival must be flagged before the order is placed.
Substance and classification
| Active substance | Fluorouracil, Combinations |
|---|---|
| ATC code | L01BC52 |
| AHFS class | 10:00.00 ; 84:28.00 |
| Biosimilar biologic | No |
Health Canada record and identifiers
The regulatory facts straight from the Drug Product Database, plus every identifier form Nexara accepts on a purchase order. A DIN written without its leading zeros is the commonest reason an order line fails to match.
| DIN (8-digit, as used in ordering) | 02428946 |
|---|---|
| DIN (unpadded, as printed on some documents) | 2428946 |
| Brand name | ACTIKERALL |
| Generic / active ingredient | SALICYLIC ACID : 10 % FLUOROURACIL : 0.5 % |
| Market authorization holder | CIPHER PHARMACEUTICALS INC |
| Health Canada schedule | Prescription |
| ATC code | L01BC52 |
| ATC anatomical main group | L — Antineoplastic and immunomodulating agents |
| ATC therapeutic subgroup | L01BC |
| Current status | MARKETED |
| Status date | 19-Feb-2016 |
| Original market date | 2016-02-19 00:00:00 |
| Status source | Live Health Canada DPD sync |
Verify on the primary sources
What can be used instead?
Alternatives on every axis a buyer actually considers — the same molecule in another presentation, the same class, an adjacent class, or a fixed-dose combination. Every row is led by the marketed DIN count, because that is what can be bought this week.
2 · Same class — other molecules in ATC L01BC
| Molecule | Canadian brands | DINs | Marketed | Sourceable |
|---|---|---|---|---|
| Capecitabine | ACH-CAPECITABINE · APO-CAPECITABINE · CAPECITABINE · MINT-CAPECITABINE · +4 more | 20 | 11 | Yes |
| Azacitidine | AZACITIDINE FOR INJECTION · NAT-AZACITIDINE · ONUREG · PMS-AZACITIDINE FOR INJECTION · +2 more | 14 | 7 | Yes |
| Fluorouracil | ADRUCIL · ADRUCIL INJ 50MG/ML · EFUDEX · FLUOROPLEX CREAM 1% · +4 more | 15 | 6 | Yes |
| Cytarabine | AJ-CYTARABINE · CYTARABINE - PWS 1GN/VIAL · CYTARABINE - PWS 2GM/VIAL · CYTARABINE - PWS 500MG/VIAL · +8 more | 19 | 3 | Yes |
| Gemcitabine | ACT GEMCITABINE · AJ-GEMCITABINE · GEMCITABINE FOR INJECTION · GEMCITABINE FOR INJECTION CONCENTRATE · +7 more | 38 | 2 | Yes |
| Trifluridine, Combinations | LONSURF | 2 | 2 | Yes |
| Decitabine | DACOGEN · DEMYLOCAN | 2 | 1 | Yes |
| Fluorouracil, Combinations | ACTIKERALL | 1 | 1 | Yes |
| Decitabine, Combinations | INQOVI | 1 | 1 | Yes |
A molecule with zero marketed DINs cannot be sourced domestically, however many approvals it holds — if one of these sits on a formulary or in an older protocol, that is the line to check.
3 · Adjacent classes in ATC L01B
| ATC subgroup | Molecules | DINs | Marketed |
|---|---|---|---|
| L01BA | Methotrexate · Pemetrexed · Pralatrexate% · Raltitrexed | 90 | 36 |
| L01BB | Cladribine · Clofarabine · Fludarabine · Mercaptopurine · Nelarabine · +1 more | 18 | 10 |
Not clinical advice. These tables describe what can be supplied in Canada, not what should be prescribed. Substitution within or across classes is a prescriber and pharmacist decision, and interchangeability is determined provincially.
How can I get it?
Nexara Health supplies this product to licensed Canadian buyers — pharmacies, hospitals, clinics, licensed distributors, and clinical trial sponsors or their CROs. We confirm stock, pack size, expiry and pricing at the time of quotation. If the product is on backorder or in shortage, we identify equivalent alternatives and import options where permitted.
Ordering questions
Who can buy this from Nexara?
Licensed entities only. Nexara holds Health Canada establishment licence DEL 3-002896-A and ships only to a licensed address. Patients and unlicensed buyers are routed to a partner pharmacy.
Is there a minimum order?
Yes, set per product line and per pack multiple rather than on the order total, so you are never asked to buy a part-pack. The minimum for this line is confirmed with your quote.
What is the lead time?
Confirmed per order at quotation, and it depends on current stock position and whether the product is in shortage.
Why is there no price on this page?
Nexara quotes a delivered Canadian price per order, against a verified licence. Foreign list prices are published on incompatible bases and are not a guide to what any buyer can obtain here, so this page shows which markets list the molecule and on what basis, and nothing more.
Can Nexara supply this for a clinical trial?
Yes — comparator and background-therapy supply, including sourcing from other markets where a Canadian pack will not satisfy the protocol. Clinical trial supply.