Rx Item-Aldara 5% Cream 12X0.2 5gm By Valeant Pharma

Clinical Information
Gen. Code and Des.
31099 imiquimod TOPICAL CREAM PACK 5 %
GCN and Des.
54201 imiquimod TOPICAL CREAM PACK 5 %
Strength
5%
Dose Form
CREAM IN PACKET (EA)
Product Category
RX Pharmaceuticals
Fine Line Class
850085008510 All Rx Products
DEA Class
NC
OMP Family

AHFS Class
84920000 SKIN AND MUCOUS MEMBRANE AGENTS, MISC.
Active Ingredients
6479 imiquimod 99011026
Inactive Ingredients
3192 benzyl alcohol 100516
3203 paraben 99967
7543 sorbitan esters





ALDARA- imiquimod cream
Graceway Pharmaceuticals, LLC
INDICATIONS AND USAGE
1.1 Actinic Keratosis
Aldara Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses on the face or scalp in immunocompetent adults.
1.2 Superficial Basal Cell Carcinoma
Aldara Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with maximum tumor diameter of 2.0 cm, located on the trunk (excluding anogenital skin), neck, or extremities (excluding hands and feet), only when surgical methods are medically less appropriate and patient follow-up can be reasonably assured.
The histological diagnosis of superficial basal cell carcinoma should be established prior to treatment, since safety and efficacy of Aldara Cream have not been established for other types of basal cell carcinomas, including nodular and morpheaform (fibrosing or sclerosing) types.
1.3 External Genital Warts
Aldara Cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in patients 12 years old or older.
1.4 Limitations of Use
Aldara Cream has been evaluated in children ages to 12 years with molluscum contagiosum and these studies failed to demonstrate efficacy [see Use in Specific Populations ].
1.5 Unevaluated Populations
The safety and efficacy of Aldara Cream in immunosuppressed patients have not been established.
Aldara Cream should be used with caution in patients with pre-existing autoimmune conditions.
The efficacy and safety of Aldara Cream have not been established for patients with Basal Cell Nevus Syndrome or Xeroderma Pigmentosum.
2 DOSAGE AND ADMINISTRATION
The application frequency for Aldara Cream is different for each indication.
Aldara is not for oral, ophthalmic, or intravaginal use.
2.1 Actinic Keratosis
Aldara Cream should be applied times per week for full 16 weeks to defined treatment area on the face or scalp (but not both concurrently). The treatment area is defined as one contiguous area of approximately 25 cm2 (e.g., cm 5 cm) on the face (e.g. forehead or one cheek) or on the scalp. Examples of times per week application schedules are Monday and Thursday, or Tuesday and Friday. Aldara Cream should be applied to the entire treatment area and rubbed in until the cream is no longer visible. No more than one packet of Aldara Cream should be applied to the contiguous treatment area at each application. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately hours, after which time the cream should be removed by washing the area with mild soap and water.
2.2 Superficial Basal Cell Carcinoma
Aldara Cream should be applied times per week for full weeks to biopsy-confirmed superficial basal cell carcinoma. An example of 5 times per week application schedule is to apply Aldara Cream, once per day, Monday through Friday. Aldara Cream should be applied prior to normal sleeping hours and left on the skin for approximately hours, after which time the cream should be removed by washing the area with mild soap and water. The prescriber should demonstrate the proper application technique to maximize the benefit of Aldara Cream therapy.
2.3 External Genital Warts
Aldara Cream should be applied times per week to external genital/perianal warts. Aldara Cream treatment should continue until there is total clearance of the genital/perianal warts or for maximum of 16 weeks. Examples of times per week application schedules are: Monday, Wednesday, Friday or Tuesday, Thursday, Saturda
3 DOSAGE FORMS AND STRENGTHS
Aldara (imiquimod) Cream, 5%, is supplied in single-use packets each of which contains 250 mg of the cream, equivalent to 12.5 mg of imiquimod. Aldara Cream is supplied in boxes of 12 packets each.

Rx Item-Aldara 5% Cream 12X0.2 5gm By Va
NDC No.99207-0260-12 UPC/GTIN No.3-99207-26012-7 MPN No. 29102 Only Lic.-Physician, Pharmacy, Dentist, Drug Mfg, Dist., Gov, Hospital, Lic.Lab, Naturalist, Naturopath, NP, Optometrist, Pharmacist, PA,

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Valeant Pharma

IMIQUIMOD TOPICAL CREAM P
Only Lic.-Physician,Pharmacy,Dentist,Drug Mfg,Dist.,Gov,Hospital,Lic.Lab,Naturalist,Naturopath,NP,Optometrist,Pharmacist,PA,Physical Therapist,Podiatrist,Research Co.,Uni.,VA,Vet & Wholesalers in scop

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Drug Info from Dailymed
Drug Info from Dailymed