MYDRIATIC-4- tropicamide - proparacine - phenylephrine - ketorolac solution/ drops

Mydriatic-4 by

Drug Labeling and Warnings

Mydriatic-4 by is a Prescription medication manufactured, distributed, or labeled by Imprimis NJOF, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STORAGE AND HANDLING

Store at 20° to 25° C (68° to 77° F)​

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MYDRIATIC-4 
tropicamide - proparacine - phenylephrine - ketorolac solution/ drops

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 71384-632
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6)	TROPICAMIDE	10 mg  in 1 mL
KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L)	KETOROLAC TROMETHAMINE	5 mg  in 1 mL
PROPARACAINE HYDROCHLORIDE (UNII: U96OL57GOY) (PROPARACAINE - UNII:B4OB0JHI1X)	PROPARACAINE HYDROCHLORIDE	5 mg  in 1 mL
PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV)	PHENYLEPHRINE HYDROCHLORIDE	25 mg  in 1 mL

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 71384-632-05	5 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product	05/01/2018

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		05/01/2018

Labeler - Imprimis NJOF, LLC (080431967)