Application Nr Approved Date Route Status External Links
ANDA078548 2010-02-25 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage Imiquimod Cream Is Indicated For The Topical Treatment Of: Clinically Typical, Nonhyperkeratotic, Nonhypertrophic Actinic Keratoses (ak) On The Face Or Scalp In Immunocompetent Adults (1.1) External Genital And Perianal Warts/condyloma Acuminata In Patients 12 Years Old 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 Imiquimod Cream Is Indicated For The Topical Treatment Of Clinically Typical, Nonhyperkeratotic, Nonhypertrophic Actinic Keratoses On The Face Or Scalp In Immunocompetent Adults. 1.3 External Genital Warts Imiquimod 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 Imiquimod 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 Imiquimod Cream In Immunosuppressed Patients Have Not Been Established. Imiquimod Cream Should Be Used With Caution In Patients With Pre-Existing Autoimmune Conditions. The Efficacy And Safety Of Imiquimod 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. Oleic Acid OLEIC ACID Molecular CTG-Component or coating , MISC-Miscellaneous GRAS-Generally recognized as safe.
2. 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.
3. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
4. Stearyl Alcohol STEARYL ALCOHOL Molecular
5. Benzyl Alcohol BENZYL ALCOHOL Molecular
6. Cetyl Alcohol CETYL ALCOHOL Molecular
7. 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.
8. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.
9. Methylparaben METHYLPARABEN Molecular PRES-Chemical preservative REG-Food additives for which a petition has been filed and a regulation issued.

Active Ingredients ( 1 Total)

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

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