Quốc gia: Hoa Kỳ
Ngôn ngữ: Tiếng Anh
Nguồn: NLM (National Library of Medicine)
CICLOPIROX (UNII: 19W019ZDRJ) (CICLOPIROX - UNII:19W019ZDRJ), CLOBETASOL PROPIONATE (UNII: 779619577M) (CLOBETASOL - UNII:ADN79D536H)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
CICLOPIROX 1% / CLOBETASOL PROPIONATE 0.05%- CICLOPIROX 1% / CLOBETASOL PROPIONATE 0.05% SHAMPOO SINCERUS FLORIDA, LLC _Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been_ _approved by FDA. For further information about unapproved drugs, click here._ ---------- CICLOPIROX 1% / CLOBETASOL PROPIONATE 0.05% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC ADVERSE REACTIONS. ACTIVE, INACTIVE NDC 72934-7037-6 CICLOPIROX USP 1% / CLOBETASOL PROPIONATE USP 0.05%. SHAMPOO 120GM. CICLOPIROX 1% / CLOBETASOL PROPIONATE 0.05% ciclopirox 1% / clobetasol propionate 0.05% shampoo PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-70 37 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH CICLO PIRO X (UNII: 19 W0 19 ZDRJ) (CICLOPIROX - UNII:19 W0 19 ZDRJ) CICLOPIROX 1 g in 10 0 g CLO BETASO L PRO PIO NATE (UNII: 779 6 19 577M) (CLOBETASOL - UNII:ADN79 D536 H) CLOBETASOL PROPIONATE 0 .0 5 g in 10 0 g PRODUCT CHARACTERISTICS COLOR ye llo w S CORE Sincerus Florida, LLC S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:729 34-70 37-6 120 g in 1 CYLINDER; Type 0 : No t a Co mbinatio n Pro duct 0 5/0 1/20 19 MARKETING INFORMATION MARKE TING CATE GORY APPLICATION NUMBE R OR MONOGRAPH CITATION MARKE TING START DATE MARKE TING END DATE unappro ved drug o ther 0 5/0 1/20 19 LABELER - Sincerus Florida, LLC (080105003) ESTABLISHMENT NAME AD D RE S S ID/FEI BUSINE SS OPE RATIONS Sincerus Flo rida, LLC 0 8 0 10 50 0 3 ma nufa c ture (729 34-70 37) Revised: 4/2019 Đọc toàn bộ tài liệu