Application Nr Approved Date Route Status External Links
NDA020723 1997-02-27 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Aldara Cream Is Indicated For The Topical Treatment Of: •clinically Typical, Nonhyperkeratotic, Nonhypertrophic Actinic Keratoses (aks) On The Face Or Scalp In Immunocompetent Adults. (1.1) •biopsy-Confirmed, Primary Superficial Basal Cell Carcinoma (sbcc) In Immunocompetent Adults; Maximum Tumor Diameter Of 2.0 Cm On Trunk, Neck, Or Extremities (excluding Hands And Feet), Only When Surgical Methods Are Medically Less Appropriate And Patient Follow-Up Can Be Reasonably Assured. (1.2) •external Genital And Perianal Warts/condyloma Acuminata In Patients 12 Years Or Older. (1.3) Limitations Of Use: Efficacy Was Not Demonstrated For Molluscum Contagiosum In Children Aged 2–12. (1.4, 8.4) 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 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. 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 Or Older. 1.4 Limitations Of Use Aldara Cream Has Been Evaluated In Children Ages 2 To 12 Years With Molluscum Contagiosum And These Studies Failed To Demonstrate Efficacy [see Use In Specific Populations (8.4)]. 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.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Cetyl Alcohol CETYL ALCOHOL Molecular
2. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
3. Isostearic Acid ISOSTEARIC ACID Molecular
4. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
5. Polysorbate 60 POLYSORBATE 60 Unresolved AF-Antifoaming (or defoaming) agent , EMUL-Emulsifier , FEED-Feed additives , MISC-Miscellaneous REG-Food additives for which a petition has been filed and a regulation issued.
6. Propylparaben PROPYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.
7. Water WATER Molecular
8. Sorbitan Monostearate SORBITAN MONOSTEARATE Molecular AF-Antifoaming (or defoaming) agent , CTG-Component or coating , EMUL-Emulsifier , FEED-Feed additives FS-Substances permitted as optional ingredient in a standardized food.
9. Stearyl Alcohol STEARYL ALCOHOL Molecular

Active Ingredients ( 1 Total)

Name Structure ZINC ID(s)
1. Imiquimod IMIQUIMOD ZINC19632912

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