País: Estados Unidos
Língua: inglês
Origem: NLM (National Library of Medicine)
BENZOCAINE (UNII: U3RSY48JW5) (BENZOCAINE - UNII:U3RSY48JW5), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987), TETRACAINE (UNII: 0619F35CGV) (TETRACAINE - UNII:0619F35CGV)
Sincerus Florida, LLC
TOPICAL
PRESCRIPTION DRUG
unapproved drug other
BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10%- BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% 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._ ---------- BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% DIRECTIONS FOR USE SINCERUS FLORIDA, LLC. ADVERSE REACTIONS ACTIVE, INACTIVE NDC 72934- 2009-2 BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% . CREAM 30 GM BENZOCAINE 20% / LIDOCAINE 10% / TETRACAINE 10% benzocaine 20% / lidocaine 10% / tetracaine 10% cream PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:729 34-20 0 9 ROUTE OF ADMINISTRATION TOPICAL ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH BENZO CAINE (UNII: U3RSY48 JW5) (BENZOCAINE - UNII:U3RSY48 JW5) BENZOCAINE 20 g in 10 0 g LIDO CAINE (UNII: 9 8 PI20 0 9 8 7) (LIDOCAINE - UNII:9 8 PI20 0 9 8 7) LIDOCAINE 10 g in 10 0 g TETRACAINE (UNII: 0 6 19 F35CGV) (TETRACAINE - UNII:0 6 19 F35CGV) TETRACAINE 10 g in 10 0 g Sincerus Florida, LLC PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:729 34-20 0 9 - 2 30 g in 1 BOTTLE, PUMP; Type 0 : No t a Co mbinatio n Pro duc t 0 5/22/20 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 5/22/20 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 0 9 ) Revised: 5/2019 Leia o documento completo