Country: Amerika Syarikat
Bahasa: Inggeris
Sumber: NLM (National Library of Medicine)
TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6), KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L), PROPARACAINE HYDROCHLORIDE (UNII: U96OL57GOY) (PROPARACAINE - UNII:B4OB0JHI1X), PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)
Imprimis NJOF, LLC
OPHTHALMIC
PRESCRIPTION DRUG
unapproved drug other
MYDRIATIC-4- TROPICAMIDE - PROPARACINE - PHENYLEPHRINE - KETOROLAC SOLUTION/ DROPS IMPRIMIS NJOF, 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._ ---------- STORE AT 20° TO 25° C (68° TO 77° F) MYDRIATIC-4 tropicamide - proparacine - phenylephrine - ketorolac solution/ drops PRODUCT INFORMATION PRODUCT T YPE HUMAN PRESCRIPTION DRUG ITE M CODE (SOURCE ) NDC:7138 4-6 32 ROUTE OF ADMINISTRATION OPHTHALMIC ACTIVE INGREDIENT/ACTIVE MOIETY INGREDIENT NAME BASIS OF STRENGTH STRE NG TH TRO PICAMIDE (UNII: N0 A3Z5XTC6 ) (TROPICAMIDE - UNII:N0 A3Z5XTC6 ) TROPICAMIDE 10 mg in 1 mL KETO RO LAC TRO METHAMINE (UNII: 4EVE59 46 BQ) (KETOROLAC - UNII:YZI510 5V0 L) KETOROLAC TROMETHAMINE 5 mg in 1 mL PRO PARACAINE HYDRO CHLO RIDE (UNII: U9 6 OL57GOY) (PROPARACAINE - UNII:B4OB0 JHI1X) PROPARACAINE HYDROCHLORIDE 5 mg in 1 mL PHENYLEPHRINE HYDRO CHLO RIDE (UNII: 0 4JA59 TNSJ) (PHENYLEPHRINE - UNII:1WS29 7W6 MV) PHENYLEPHRINE HYDROCHLORIDE 25 mg in 1 mL PACKAG ING # ITEM CODE PACKAGE DESCRIPTION MARKETING START DATE MARKETING END DATE 1 NDC:7138 4-6 32- 0 5 5 mL in 1 BOTTLE, DROPPER; Type 0 : No t a Co mbinatio n Pro duc t 0 5/0 1/20 18 Imprimis NJOF, LLC 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 1/20 18 LABELER - Imprimis NJOF, LLC (080431967) Revised: 5/2018 Baca dokumen lengkap