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HSA Approval

ALDARA CREAM 5%

SIN10105P

ALDARA CREAM 5%

ALDARA CREAM 5%

September 17, 1998

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Regulatory Information

HSA regulatory responsibility and product classification details

Regulatory Responsibility

RegistrantINOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED
Licence HolderINOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

Product Classification

D
Drug Type
Therapeutic
F
Forensic Class
Prescription Only
HSA Singapore Classification

Formulation Information

CREAM

**DOSAGE AND ADMINISTRATION** Aldara cream is to be applied 3 times per week, prior to normal sleeping hours, and left on the skin for 6–10 hours. Following the treatment period, cream should be removed by washing the treated area with mild soap and water. Examples of 3 times per week application schedules are: Monday, Wednesday, Friday; or Tuesday, Thursday, Saturday application prior to sleeping hours. Aldara treatment should continue until there is total clearance of the genital/perianal warts or for a maximum of 16 weeks. Local skin reactions (erythema) at the treatment site are common. A rest period of several days may be taken if required by the patient’s discomfort or severity of the local skin reaction. Treatment may resume once the reaction subsides. Non-occlusive dressings such as cotton gauze or cotton underwear may be used in the management of skin reactions. The technique for proper dose administration should be demonstrated by the prescriber to maximize the benefit of Aldara therapy. Handwashing before and after cream application is recommended. Aldara 5% cream is packaged in single-use sachets which contain sufficient cream to cover a wart area of up to 20 cm2: use of excessive amounts of cream should be avoided. Patients should be instructed to apply Aldara cream to external genital/perianal warts. A thin layer is applied to the wart area and rubbed in until the cream is no longer visible. The application site is not to be occluded.

TOPICAL

Medical Information

**INDICATIONS AND USAGE** Aldara 5% cream is indicated for the treatment of external genital and perianal warts/condyloma acuminata in adults.

**CONTRAINDICATIONS** None known

D06BB10

imiquimod

Manufacturer Information

INOVA PHARMACEUTICALS (SINGAPORE) PTE. LIMITED

3M HEALTH CARE LIMITED

Ensign Laboratories Pty Ltd

Active Ingredients

IMIQUIMOD

5%

Imiquimod

Documents

Package Inserts

Aldara Cream PI.pdf

Approved: June 21, 2023

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ALDARA CREAM 5% - HSA Approval | MedPath