Label: ORIOX COOL BREATH ORAL RINSE MILD- sodium benzoate liquid

  • Category: HUMAN OTC DRUG LABEL

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.

Drug Label Information

Updated March 24, 2022

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  • ACTIVE INGREDIENT

    sodium benzoate

  • Package Label - Principal Display Panel

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  • INGREDIENTS AND APPEARANCE
    ORIOX COOL BREATH ORAL RINSE MILD 
    sodium benzoate liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:77932-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM BENZOATE (UNII: OJ245FE5EU) (BENZOIC ACID - UNII:8SKN0B0MIM) SODIUM BENZOATE0.3 g  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    SORBITOL (UNII: 506T60A25R)  
    ALLANTOIN (UNII: 344S277G0Z)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:77932-001-011500 mL in 1 BOTTLE; Type 0: Not a Combination Product03/25/2022
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    unapproved drug other03/25/2022
    Labeler - LCC LTD (688785286)
    Establishment
    NameAddressID/FEIBusiness Operations
    LCC LTD688785286manufacture(77932-001)