Valsts: Amerikas Savienotās Valstis
Valoda: angļu
Klimata pārmaiņas: NLM (National Library of Medicine)
UREA (UNII: 8W8T17847W) (UREA - UNII:8W8T17847W), HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY), TACROLIMUS (UNII: WM0HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20%- HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20% 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._ ---------- HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC. ADVERSE REACTIONS ACTIVE, INACTIVE NDC 72934- 2097-2 HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS USP 0.1% / UREA USP 20%. CREAM 30GM. HYALURONIC ACID SODIUM SALT 1% / TACROLIMUS 0.1% / UREA 20% hyaluronic acid sodium salt 1% / tacrolimus 0.1% / urea 20% cream PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-20 9 7 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH UREA (UNII: 8 W8 T178 47W) (UREA - UNII:8 W8 T178 47W) UREA 20 g in 10 0 g HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH) (HYALURONIC ACID - UNII:S270 N0 TRQY) HYALURONATE SODIUM 1 g in 10 0 g TACRO LIMUS (UNII: WM0 HAQ4WNM) (TACROLIMUS ANHYDROUS - UNII:Y5L2157C4J) TACROLIMUS ANHYDROUS 0 .1 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 34-20 9 7- 2 30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 5/17/20 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 5/17/20 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 9 7) Revised: 5/2019 Izlasiet visu dokumentu