Country: United States
Language: English
Source: NLM (National Library of Medicine)
AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT), NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
AZELAIC ACID 15% / NIACINAMIDE 4%- AZELAIC ACID 15% / NIACINAMIDE 4% CREAM 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._ ---------- AZELAIC ACID 15% / NIACINAMIDE 4% ACTIVE, INACTIVE DIRECTIONS FOR USE SINCERUS FLORIDA, LLC ADVERSE REACTIONS. NDC 72934-2008-2 AZELAIC ACID 15%, NIACINAMIDE USP 4%, CREAM 30GM AZELAIC ACID 15% / NIACINAMIDE 4% azelaic acid 15% / niacinamide 4 % cream Sincerus Florida, LLC PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-20 0 8 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH AZELAIC ACID (UNII: F2VW3D43YT) (AZELAIC ACID - UNII:F2VW3D43YT) AZELAIC ACID 15 g in 10 0 g NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4) NIACINAMIDE 4 g in 10 0 g PRODUCT CHARACTERISTICS COLOR white 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 34-20 0 8 - 2 30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 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 34-20 0 8 ) Revised: 4/2019 Read the complete document