Land: Verenigde Staten
Taal: Engels
Bron: NLM (National Library of Medicine)
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
NIACINAMIDE 4% / TRETINOIN 0.1%- NIACINAMIDE 4% / TRETINOIN 0.1% 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._ ---------- NIACINAMIDE 4%/ TRETINOIN 0.1% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC ADVERSE REACTIONS. ACTIVE, INACTIVE NDC 72934-2168-2 NIACINAMIDE 4 / TRETINOIN 0.01 CREAM 30GM NIACINAMIDE 4% / TRETINOIN 0.1% niacinamide 4 % / tretinoin 0.1% cream PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-216 8 Sincerus Florida, LLC 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 TRETINO IN (UNII: 56 8 8 UTC0 1R) (TRETINOIN - UNII:56 8 8 UTC0 1R) TRETINOIN 0 .1 g in 10 0 g PRODUCT CHARACTERISTICS COLOR ye llo w 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 34-216 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 34-216 8 ) Revised: 1/2020 Lees het volledige document