Application Nr Approved Date Route Status External Links
NDA022483 2011-07-15 Topical RX Google , Wikipedia , PubMed , DailyMed , Raw OpenFDA , ECHA , ToxNet , JECFA , FAO , 21 CFR

Indications and Purposes

1 Indications And Usage •zyclara Cream, 2.5% And 3.75% Are Indicated For The Topical Treatment Of Clinically Typical, Visible Or Palpable Actinic Keratoses (ak) Of The Full Face Or Balding Scalp In Immunocompetent Adults. (1.1) •zyclara Cream, 3.75% Is Also Indicated For The Topical Treatment Of External Genital And Perianal Warts/condyloma Acuminata (egw) In Patients 12 Years Or Older. (1.2) •limitations Of Use: Efficacy Of Imiquimod Cream Was Not Demonstrated For Molluscum Contagiosum In Children 2 To 12 Years Of Age. (1.3, 8.4) 1.1 Actinic Keratosis Zyclara Cream, 2.5% And 3.75% Are Indicated For The Topical Treatment Of Clinically Typical Visible Or Palpable, Actinic Keratoses (ak) Of The Full Face Or Balding Scalp In Immunocompetent Adults. 1.2 External Genital Warts Zyclara Cream, 3.75% Is Indicated For The Treatment Of External Genital And Perianal Warts (egw)/condyloma Acuminata In Patients 12 Years Or Older. 1.3 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)]. Treatment With Zyclara Cream Has Not Been Studied For Prevention Or Transmission Of Hpv. 1.4 Unevaluated Populations The Safety And Efficacy Of Zyclara Cream Have Not Been Established In The Treatment Of: •urethral, Intravaginal, Cervical, Rectal Or Intra-Anal Human Papilloma Viral Disease. •actinic Keratosis When Treated With More Than One 2-Cycle Treatment Course In The Same Area. •patients With Xeroderma Pigmentosum. •superficial Basal Cell Carcinoma. •immunosuppressed Patients.

All Formulated Excipients (9 Total)

Name Structure Kind Function Status
1. Cetyl Alcohol CETYL ALCOHOL Molecular
2. Stearyl Alcohol STEARYL ALCOHOL Molecular
3. 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.
4. 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.
5. Glycerin GLYCERIN Molecular MISC-Miscellaneous FS-Substances permitted as optional ingredient in a standardized food.
6. Xanthan Gum XANTHAN GUM Unresolved EMUL-Emulsifier FS-Substances permitted as optional ingredient in a standardized food.
7. Water WATER Molecular
8. Benzyl Alcohol BENZYL ALCOHOL Molecular
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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