Label: FRESH CLEAR- phenylephrine hydrochloride solution/ drops

  • NDC Code(s): 0023-0000-01, 0023-0000-02
  • Packager: Allergan, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Export only

Drug Label Information

Updated February 1, 2019

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  • Principal Display Panel- 1.2% / 1.4% 15 mL Carton Label

    FRESHCLEAR®

    Fenilefrina,
    Alcohol Polivinílico
    Solución estéril

    0.12 % / 1.4 %

    Caja con frasco gotero con 15 mL

    ®ALLERGAN

    FRESHCLEAR® Fenilefrina, Alcohol Polivinílico Solución estéril 0.12 % / 1.4 % Caja con frasco gotero con 15 mL ®ALLERGAN

  • Principal Display Panel - 0.12% 15 mL Carton Label

    AllerganTM

    FRESHCLEAR® 

    FENILEFRINA
    CLORHIDRATO 0,12%

    Solución
    Oftálmica

    Estéril 15 mL

    ALLERGAN™ Rx phenylephrine hydrochloride; polyvinyl alcohol Fresh Clear® 15 mL sterile

  • INGREDIENTS AND APPEARANCE
    FRESH CLEAR 
    phenylephrine hydrochloride solution/ drops
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0023-0000
    Route of AdministrationOPHTHALMIC
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    phenylephrine hydrochloride (UNII: 04JA59TNSJ) (phenylephrine - UNII:1WS297W6MV) phenylephrine hydrochloride1.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    edetate disodium (UNII: 7FLD91C86K)  
    POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)  
    sodium phosphate, dibasic, heptahydrate (UNII: 70WT22SF4B)  
    sodium phosphate, monobasic, monohydrate (UNII: 593YOG76RN)  
    sodium acetate (UNII: 4550K0SC9B)  
    sodium thiosulfate (UNII: HX1032V43M)  
    water (UNII: 059QF0KO0R)  
    benzalkonium chloride (UNII: F5UM2KM3W7)  
    hydrochloric acid (UNII: QTT17582CB)  
    sodium hydroxide (UNII: 55X04QC32I)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0023-0000-011 in 1 CARTON11/01/2011
    115 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    2NDC:0023-0000-021 in 1 CARTON11/01/2011
    23 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Export only11/01/2011
    Labeler - Allergan, Inc. (144796497)
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