Aldara 5% Cream



ALDARA 5 percent cream

In a 250 mg cream, each sachet contains 12.5 mg imiquimod (5 percent ).

Iquimod is present in 100 mg of cream.

Excipients with known side effects include:

2.0 mg/g cream methyl hydroxybenzoate (E 218)

0.2 mg/g cream propyl hydroxybenzoate (E 216)

22.0 mg/g cream cetyl alcohol

31.0 mg/g cream stearyl alcohol

Section 6.1 contains a complete list of excipients.

Imiquimod cream is used to treat the following conditions:

Adults develop external genital and perianal warts (condylomata acuminata).

Adults with small superficial basal cell carcinomas (sBCCs).

Clinically typical nonhyperkeratotic, nonhypertrophic actinic keratoses (AKs) on the face or scalp in immunocompetent adult patients when the size or number of lesions limits cryotherapy efficacy and/or acceptability and other topical treatment options are contraindicated or less appropriate.

Adults with external genital warts:

Imiquimod cream should be applied three times per week (for example, Monday, Wednesday, and Friday; or Tuesday, Thursday, and Saturday) before going to bed and should last for six to ten hours. Imiquimod cream should be used until visible genital or perianal warts have disappeared, or for a maximum of 16 weeks per episode of warts.

Administration method:

Genital warts on the outside:

Imiquimod cream should be applied in a thin layer to the clean wart area and rubbed in until it disappears. Avoid applying to internal surfaces and only apply to affected areas. Imiquimod cream should be applied before going to sleep. Showering or bathing should be avoided during the 6 to 10 hour treatment period. It is critical to remove imiquimod cream with mild soap and water after this time period. An excessive amount of cream or prolonged skin contact can cause a severe application site reaction (see sections 4.4, 4.8 and 4.9). A single-use sachet is enough to cover a 20 cm2 wart area (approx. 3 inches2). Once opened, sachets should not be reused. Hands should be thoroughly washed before and after applying the cream.

Uncircumcised males with foreskin warts should retract the foreskin and wash the area every day (see section 4.4).


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