FDA label
What is imiquimod used for?
The FDA-approved uses of imiquimod, quoted from the Indications and Usage section of its DailyMed label.
Source: DailyMed SPL label file dated 2026-10-23. Publisher page
The FDA label for imiquimod lists 3 uses: Actinic Keratosis; Superficial Basal Cell Carcinoma; External Genital Warts.
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Imiquimod, cream
Indications and Usage, quoted from the label by Padagis Israel Pharmaceuticals Ltd (ANDA078837). Cross-references to other label sections are left out.
Actinic Keratosis
Imiquimod Cream is indicated for the topical treatment of clinically typical, nonhyperkeratotic, nonhypertrophic actinic keratoses (AK) on the face or scalp in immunocompetent adults.
Superficial Basal Cell Carcinoma
Imiquimod Cream is indicated for the topical treatment of biopsy-confirmed, primary superficial basal cell carcinoma (sBCC) in immunocompetent adults, with a 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.
Establish the histological diagnosis of superficial basal cell carcinoma prior to treatment. The safety and effectiveness of Imiquimod Cream have not been established for other types of basal cell carcinomas (BCC), including nodular and morpheaform (fibrosing or sclerosing) types.
External Genital Warts
Imiquimod Cream is indicated for the topical treatment of external genital and perianal warts (EGW) in immunocompetent patients 12 years of age and older.
Source: DailyMed label, set id 1505cf54-37da-4b2b-9812-6ffd6a01a7c7, version 14, effective September 30, 2025. NDC 45802-368, one of 9 listings for this product.
Questions
What is imiquimod used for?
The FDA label for imiquimod lists 3 uses: Actinic Keratosis; Superficial Basal Cell Carcinoma; External Genital Warts.
Does this page cover off-label uses or dosing?
No. This page shows only the Indications and Usage section of the FDA label. Ask a pharmacist or prescriber about dosing.