Label: MYDRIATIC-3- tropicamide - cyclopentolate - phenylephrine solution/ drops
- NDC Code(s): 71384-631-05
- Packager: Imprimis NJOF LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated May 8, 2018
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- STORAGE AND HANDLING
Store at 20° to 25° C (68° to 77° F)
- INGREDIENTS AND APPEARANCE
tropicamide - cyclopentolate - phenylephrine solution/ drops
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:71384-631 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 CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J) CYCLOPENTOLATE HYDROCHLORIDE 10 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:71384-631-05 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)