מדינה: ארצות הברית
שפה: אנגלית
מקור: NLM (National Library of Medicine)
PENTOXIFYLLINE (UNII: SD6QCT3TSU) (PENTOXIFYLLINE - UNII:SD6QCT3TSU), TRIAMCINOLONE ACETONIDE (UNII: F446C597KA) (TRIAMCINOLONE ACETONIDE - UNII:F446C597KA)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1%- PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1% 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._ ---------- PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC. ADVERSE REACTIONS ACTIVE, INACTIVE NDC 72934- 1169-2 PENTOXIFYLLINE USP 0.5% / TRIAMCINOLONE ACETONIDE USP 0.1%. GEL 30GM. PENTOXIFYLLINE 0.5% / TRIAMCINOLONE ACETONIDE 0.1% pentoxifylline 0.5% / triamcinolone acetonide 0.1% gel PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-116 9 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH PENTO XIFYLLINE (UNII: SD6 QCT3TSU) (PENTOXIFYLLINE - UNII:SD6 QCT3TSU) PENTOXIFYLLINE 0 .5 g in 10 0 g TRIAMCINO LO NE ACETO NIDE (UNII: F446 C59 7KA) (TRIAMCINOLONE ACETONIDE - UNII:F446 C59 7KA) TRIAMCINOLONE ACETONIDE 0 .1 g in 10 0 g PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:729 34-116 9 - 2 30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 5/15/20 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 5/15/20 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 34-116 9 ) Revised: 5/2019 קרא את המסמך השלם