Ország: Egyesült Államok
Nyelv: angol
Forrás: NLM (National Library of Medicine)
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), SULFACETAMIDE SODIUM (UNII: 4NRT660KJQ) (SULFACETAMIDE - UNII:4965G3J0F5)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15%- NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15% LOTION 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._ ---------- NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC. ADVERSE REACTIONS ACTIVE, INACTIVE NDC 72934-3156-2 NIACINAMIDE USP 4% / SODIUM SULFACETAMIDE MONOHYDRATE USP 15%. LOTION 30GM. NIACINAMIDE 4% / SODIUM SULFACETAMIDE MONOHYDRATE 15% niacinamide 4 % / sodium sulfacetamide monohydrate 15% lotion PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-3156 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH NIACINAMIDE (UNII: 25X51I8 RD4) (NIACINAMIDE - UNII:25X51I8 RD4) NIACINAMIDE 4 g in 10 0 g SULFACETAMIDE SO DIUM (UNII: 4NRT6 6 0 KJQ) (SULFACETAMIDE - UNII:49 6 5G3J0 F5) SULFACETAMIDE SODIUM 15 g in 10 0 g PRODUCT CHARACTERISTICS COLOR white S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS Sincerus Florida, LLC PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:729 34-3156 - 2 30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 5/11/20 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 5/11/20 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 34-3156 ) Revised: 5/2019 Olvassa el a teljes dokumentumot