Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4), SPIRONOLACTONE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232), TRETINOIN (UNII: 5688UTC01R) (TRETINOIN - UNII:5688UTC01R)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025%- NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025% GEL 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 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC ADVERSE REACTIONS ACTIVES, INACTIVES NDC 72934-1152-2. NIACINAMIDE USP 2% / SPIRONOLACTONE USP 5% / TRETINOIN USP 0.025%. GEL30GM. NIACINAMIDE 2% / SPIRONOLACTONE 5% / TRETINOIN 0.025% niacinamide 2% / spironolactone 5% / tretinoin 0.025% gel PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-1152 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 2 g in 10 0 g SPIRO NO LACTO NE (UNII: 27O7W4T232) (SPIRONOLACTONE - UNII:27O7W4T232) SPIRONOLACTONE 5 g in 10 0 g TRETINO IN (UNII: 56 8 8 UTC0 1R) (TRETINOIN - UNII:56 8 8 UTC0 1R) TRETINOIN 0 .0 25 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 34-1152- 2 30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 5/0 4/20 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 4/20 19 Sincerus Florida, LLC 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 34-1152) Revised: 5/2019 Baca dokumen lengkap