Label: RELEGARD- glacial acetic acid, oxyquinoline gel

  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

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Drug Label Information

Updated March 20, 2017

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  • DOSAGE AND ADMINISTRATION

    TO OPEN: USE TOP OF CAP TO TWIST OFF SEAL.

    FOR VAGINAL USE ONLY.

  • SPL UNCLASSIFIED SECTION

    CONTAINS: GLACIAL ACETIC ACID 0.9%, OXYQUINOLINE 0.025%, PRESERVATIVE, GLYCERIN, LACTIC ACID BUFFER, POLYETHYLENE GLYCOL 4500 AND PURIFIED WATER. THE PH OF 3.8 - 4.3 IS ADJUSTED USING 1N POTASSIUM HYDROXIDE.

  • SPL UNCLASSIFIED SECTION

    DO NOT USE IF TAMPER-RESISTANT SEAL AT OPENING HAS BEEN DISTURBED OR IS NOT VISIBLE. IF THIS SEAL HAS BEEN PUNCTURED OR IS NOT VISIBLE, RETURN PRODUCT TO PLACE OF PURCHASE.

  • SPL UNCLASSIFIED SECTION

    STORE AT ROOM TEMPERATURE.

  • SPL UNCLASSIFIED SECTION

    DO NOT TAKE BY MOUTH OR USE IN EYES.

  • SPL UNCLASSIFIED SECTION

    COMPLETE PRESCRIBING INFORMATION IS ENCLOSED.

    THIS BOX CONTAINS ONE APPLICATOR.

  • PRINCIPAL DISPLAY PANEL

    Relagard proof 7.25.02_Page_1

  • INGREDIENTS AND APPEARANCE
    RELEGARD 
    glacial acetic acid, oxyquinoline gel
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:51674-0130
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ACETIC ACID (UNII: Q40Q9N063P) (ACETIC ACID - UNII:Q40Q9N063P) ACETIC ACID0.9 mg  in 1 mL
    OXYQUINOLINE (UNII: 5UTX5635HP) (OXYQUINOLINE - UNII:5UTX5635HP) OXYQUINOLINE0.025 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    LACTIC ACID (UNII: 33X04XA5AT)  
    POLYETHYLENE GLYCOL 4500 (UNII: TVH7653921)  
    WATER (UNII: 059QF0KO0R)  
    POTASSIUM HYDROXIDE (UNII: WZH3C48M4T)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51674-0130-550 mL in 1 TUBE; Type 0: Not a Combination Product03/20/2017
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/20/2017
    Labeler - BLANSETT PHARMACAL CO (037477378)
    Establishment
    NameAddressID/FEIBusiness Operations
    BLANSETT PHARMACAL CO037477378manufacture(51674-0130)
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