Mydriatic-3 by Imprimis NJOF LLC

Mydriatic-3 by

Drug Labeling and Warnings

Mydriatic-3 by is a Prescription medication manufactured, distributed, or labeled by Imprimis NJOF LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

MYDRIATIC-3- tropicamide - cyclopentolate - phenylephrine 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)​

Bottle Label

MYDRIATIC-3 
tropicamide - cyclopentolate - phenylephrine solution/ drops
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 71384-631
Route of AdministrationOPHTHALMIC
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
TROPICAMIDE (UNII: N0A3Z5XTC6) (TROPICAMIDE - UNII:N0A3Z5XTC6) TROPICAMIDE10 mg  in 1 mL
CYCLOPENTOLATE HYDROCHLORIDE (UNII: 736I6971TE) (CYCLOPENTOLATE - UNII:I76F4SHP7J) CYCLOPENTOLATE HYDROCHLORIDE10 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: 71384-631-055 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product05/01/201807/01/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other05/01/201807/01/2019
Labeler - Imprimis NJOF LLC (080431967)

Revised: 2/2020
Document Id: 9e631dc3-1d21-1193-e053-2a95a90af06d
Set id: 6bb82e43-57f6-172e-e053-2991aa0a2e6e
Version: 2
Effective Time: 20200212
 
Imprimis NJOF LLC