Country: United States
Language: English
Source: NLM (National Library of Medicine)
MINOXIDIL (UNII: 5965120SH1) (MINOXIDIL - UNII:5965120SH1), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
MINOXIDIL 7% / NIACINAMIDE 4% S- MINOXIDIL 7% / NIACINAMIDE 4% 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._ ---------- MINOXIDIL 7% / NIACINAMIDE 4% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC. ADVERSE REACTIONS ACTIVE, INACTIVE NDC 72934-4147-8. MINOXIDIL 7% / NIACINAMIDE 4%. SOLUTION 60 GM MINOXIDIL 7% / NIACINAMIDE 4% S minoxidil 7% / niacinamide 4 % solution PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-4147 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 7 g in 10 0 g NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4) NIACINAMIDE 4 g in 10 0 g PRODUCT CHARACTERISTICS COLOR white (Clear so lutio n) 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 34-4147- 8 6 0 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 5/10 /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 5/10 /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 34-4147) Revised: 5/2019 Read the complete document