Label: AMINO ACID FRAGRANCEMOUTHWASH BLOSSOM- oral rinses liquid

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph final

DISCLAIMER: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated October 9, 2020

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  • DOSAGE & ADMINISTRATION

    Keep in a cool and dry place and aviod storage in direct sunlight.

  • INACTIVE INGREDIENT

    AQUA、GLYCERIN、SORBITOL、CALENDULA OFFICINALIS FLOWER EXTRACT、PRUNUS SPECIOSA FLOWER EXTRACT、MENTHOL、ARGININE、SUCRALOSE、PROPYLENE GLYCOL、POLOXAMER 407、BUTYLENE GLYCOL、POLYSORBATE 20、CETYLPYRIDINIUM CHLORIDE、 CITRIC ACID、FLAVOR、SODIUM BENZOATE、MENTHONE GLYCERIN ACETAL

  • INDICATIONS & USAGE

    It is recommended to use one(10ml) at a time, gargle for 30 seconds and spit out It's no need to garglewith water after use.

  • ACTIVE INGREDIENT

    SODIUM FLUORIDE

  • DO NOT USE

    Don't swallow it.

  • KEEP OUT OF REACH OF CHILDREN

    keep out of reach of children

  • PURPOSE

    gargle

  • WARNINGS

    Stopuse and aska doctor when feelinguncomfortable.

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    AMINO ACID FRAGRANCEMOUTHWASH BLOSSOM 
    oral rinses liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55409-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) SODIUM FLUORIDE0.005 g  in 10 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    CALENDULA OFFICINALIS FLOWER (UNII: P0M7O4Y7YD)  
    ARGININE (UNII: 94ZLA3W45F)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    SORBITOL (UNII: 506T60A25R)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    BUTYLENE GLYCOL (UNII: 3XUS85K0RA)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    MENTHONE 1,2-GLYCEROL KETAL, (+/-)- (UNII: 7QQ1EE6RCP)  
    PRUNUS SPECIOSA FLOWER (UNII: A78OOO9299)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55409-001-0110 mL in 1 VIAL; Type 0: Not a Combination Product10/09/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35510/09/2020
    Labeler - Shanghai Centro Network Technology Co., Ltd. (554090359)
    Establishment
    NameAddressID/FEIBusiness Operations
    Shanghai Centro Network Technology Co., Ltd.554090359manufacture(55409-001)
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