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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 Human Papillomavirus (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.
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