MYDRIATIC-4 (TROPICAMIDE - PROPARACINE - PHENYLEPHRINE - KETOROLAC) SOLUTION/ DROPS [IMPRIMIS NJOF, LLC]

MYDRIATIC-4 (TROPICAMIDE - PROPARACINE - PHENYLEPHRINE - KETOROLAC) SOLUTION/ DROPS [IMPRIMIS NJOF, LLC]
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NDC 71384-632-05
Set ID 6e11c346-99d6-e440-e053-2991aa0a79b5
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Imprimis NJOF, LLC
Generic Name
Product Class alpha-1 Adrenergic Agonist, Anticholinergic
Product Number
Application Number
  • STORAGE AND HANDLING


    Store at 20° to 25° C (68° to 77° F)​

  • PRINCIPAL DISPLAY PANEL

    Bottle Label

  • INGREDIENTS AND APPEARANCE
    MYDRIATIC-4 
    tropicamide - proparacine - phenylephrine - ketorolac solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:71384-632
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6) TROPICAMIDE10 mg  in 1 mL
    KETOROLAC TROMETHAMINE (UNII: 4EVE5946BQ) (KETOROLAC - UNII:YZI5105V0L) KETOROLAC TROMETHAMINE5 mg  in 1 mL
    PROPARACAINE HYDROCHLORIDE (UNII: U96OL57GOY) (PROPARACAINE - UNII:B4OB0JHI1X) PROPARACAINE HYDROCHLORIDE5 mg  in 1 mL
    PHENYLEPHRINE HYDROCHLORIDE (UNII: 04JA59TNSJ) (PHENYLEPHRINE - UNII:1WS297W6MV) PHENYLEPHRINE HYDROCHLORIDE25 mg  in 1 mL
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71384-632-055 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other05/01/2018
    Labeler - Imprimis NJOF, LLC (080431967)

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