Label: TRIMO-SAN- oxyquinoline sulfate and sodium lauryl sulfate jelly

  • NDC Code(s): 0295-5030-18
  • Packager: Denison Pharmaceuticals, LLC
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated September 11, 2019

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  • CONTENTS

    Hydroxyquinoline Sulfate 0.025%; Sodium Lauryl Sulfate N.F. 0.01%. Adjusted with Triethanolamine to pH 4 in water dispersible base composed of Glycerine, Carbomer N.F., Citric Acid, Sodium Citrate U.S.P., Methylparaben N.F., Perfume and Antifoam Emulsion N.F.

  • STORAGE:

    AFTER EACH USE Wipe threads of tube and the inside of the cap. RE-CAP TIGHTLY. Store at room temperature.

  • TRIMO-SAN and PREGNANCY

    TRIMO-SAN has NOT been tested for use during pregnancy.

    • CooperSurgical does not recommend the use of TRIMO-SAN during pregnancy.
    • If you wish to become pregnant, do not use TRIMO-SAN or any other personal hygiene product vaginally (douches, vaginal sprays, jellies or suppositories), for 6 hours prior to or following intercourse. Any product used within this time period could interfere with conception.
  • GENERAL INFORMATION

    Use Cap to pierce seal in head of tube

    Instructions for use inside package

    Keep this product out of the reach of children

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    TRIMO-SAN 
    oxyquinoline sulfate and sodium lauryl sulfate jelly
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0295-5030
    Route of AdministrationVAGINAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    OXYQUINOLINE SULFATE (UNII: 61VUG75Y3P) (OXYQUINOLINE - UNII:5UTX5635HP) OXYQUINOLINE0.25 mg  in 1 g
    SODIUM LAURYL SULFATE (UNII: 368GB5141J) (LAURYL SULFATE - UNII:DIQ16UC154) SODIUM LAURYL SULFATE0.1 mg  in 1 g
    Inactive Ingredients
    Ingredient NameStrength
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    TROLAMINE (UNII: 9O3K93S3TK)  
    SODIUM CITRATE (UNII: 1Q73Q2JULR)  
    CARBOMER 934 (UNII: Z135WT9208)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0295-5030-18113.4 g in 1 TUBE; Type 0: Not a Combination Product09/16/2019
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other09/16/2019
    Labeler - Denison Pharmaceuticals, LLC (001207208)
    Establishment
    NameAddressID/FEIBusiness Operations
    Denison Pharmaceuticals, LLC001207208manufacture(0295-5030)
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