Country: United States
Language: English
Source: NLM (National Library of Medicine)
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1), FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
FINASTERIDE 0.1% / MINOXIDIL 5%- FINASTERIDE 0.1% / MINOXIDIL 5% SOLUTION 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._ ---------- FINASTERIDE 0.1% / MINOXIDIL 5% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC ACTIVE, INACTIVE NDC 72934-4074-8. FINASTERIDE USP 0.1% / MINOXIDIL USP 5%. SOLUTION 60 GM Sincerus Florida, LLC FINASTERIDE 0.1% / MINOXIDIL 5% finasteride 0.1% / minoxidil 5% solution PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-40 74 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH MINO XIDIL (UNII: 59 6 5120 SH1) (MINOXIDIL - UNII:59 6 5120 SH1) MINOXIDIL 5 g in 10 0 g FINASTERIDE (UNII: 57GNO57U7G) (FINASTERIDE - UNII:57GNO57U7G) FINASTERIDE 0 .1 g in 10 0 g PRODUCT CHARACTERISTICS COLOR white (clear so lutio n) S CORE 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 34-40 74- 8 6 0 g in 1 BOTTLE, GLASS; Type 0 : No t a Co mbinatio n Pro duc t 0 5/0 9 /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 9 /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 34-40 74) Revised: 5/2019 Read the complete document