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.

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

Bottle Label

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)

Revised: 5/2018
Document Id: 6e11c346-99d7-e440-e053-2991aa0a79b5
Set id: 6e11c346-99d6-e440-e053-2991aa0a79b5
Version: 1
Effective Time: 20180501
 
Imprimis NJOF, LLC