Country: United States
Language: English
Source: NLM (National Library of Medicine)
HYALURONATE SODIUM (UNII: YSE9PPT4TH) (HYALURONIC ACID - UNII:S270N0TRQY), TAZAROTENE (UNII: 81BDR9Y8PS) (TAZAROTENE - UNII:81BDR9Y8PS)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.1%- HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 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._ ---------- HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.1% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC. ADVERSE REACTIONS ACTIVE, INACTIVE HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.1%. CREAM 30 GM HYALURONIC ACID SODIUM SALT 0.5% / TAZAROTENE 0.1% hyaluronic acid sodium salt 0.5% / tazarotene 0.1% cream PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-20 9 4 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH HYALURO NATE SO DIUM (UNII: YSE9 PPT4TH) (HYALURONIC ACID - UNII:S270 N0 TRQY) HYALURONATE SODIUM 0 .5 g in 10 0 g TAZARO TENE (UNII: 8 1BDR9 Y8 PS) (TAZAROTENE - UNII:8 1BDR9 Y8 PS) TAZAROTENE 0 .1 g in 10 0 g PRODUCT CHARACTERISTICS COLOR white S CORE S HAP E S IZ E FLAVOR IMPRINT CODE CONTAINS PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE Sincerus Florida, LLC 1 NDC:729 34-20 9 4- 2 30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 5/0 7/20 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 7/20 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 4) Revised: 5/2019 Read the complete document