Label: MOUTH FRESH- cetylpyridinium chloride spray

  • Contains inactivated NDC Code(s)
    NDC Code(s):     51414-500-01, 51414-500-02, 51414-500-03, 51414-500-04, view more
    51414-500-05, 51414-500-06, 51414-500-07, 51414-500-08, 51414-500-09, 51414-500-10, 51414-500-11, 51414-500-12, 51414-500-13, 51414-500-14, 51414-500-15, 51414-500-16, 51414-500-17
  • Packager: Yuyao Jessie Commodity Co.,Ltd.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not 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 September 12, 2012

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  • Active Ingredient

    Cetylpyridinium Chloride 0.05%

    Purpose

    Sterilization

  • Use

    sterilization

  • WARNINGS

    For External use only.
    Do not use  if you are allergic to any of the ingredients.
    When using this product Do not get into eyes,if contact occurs ,rinse throughly with water.
    Discontinue use if irritation or redness develops if condition persists for more than 72 hours consults a physician.

    keep out of reach of children

     keep out of reach of children unless under adult supervision .if seallowed ,get medical help or contact a Poison Control Center immediately.
  • Directions

    Open Cap to on position exposing nozzle Pump 1-2 sprays directly into mouth.

    Children under 6 months of age:ask a doctor

  • Inactive ingredients

    WATER (Aqua ),Alcohol,Glycerin,Sorbitol,Aroma,PEG-40 hydrogenated Castor Oil,Sodium Benzoate,Citric Acid ,Limonene

  • PRINCIPAL DISPLAY PANEL

    label

  • INGREDIENTS AND APPEARANCE
    MOUTH FRESH 
    cetylpyridinium chloride spray
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:51414-500
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.05 mL  in 100 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    DISODIUM EDTA-COPPER (UNII: 6V475AX06U)  
    CHLOROMETHYL METHYL ETHER (UNII: 334G5B96VG)  
    POTASSIUM SORBATE (UNII: 1VPU26JZZ4)  
    QUATERNIUM-15 (UNII: E40U03LEM0)  
    DISODIUM COCOAMPHODIACETATE (UNII: 18L9G3U51M)  
    ALPHA-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0)  
    POLYSORBATE 20 (UNII: 7T1F30V5YH)  
    CITRIC ACID ACETATE (UNII: DSO12WL7AU)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:51414-500-012 mL in 1 PACKAGE
    2NDC:51414-500-023 mL in 1 PACKAGE
    3NDC:51414-500-034 mL in 1 PACKAGE
    4NDC:51414-500-045 mL in 1 PACKAGE
    5NDC:51414-500-056 mL in 1 PACKAGE
    6NDC:51414-500-067 mL in 1 PACKAGE
    7NDC:51414-500-078 mL in 1 PACKAGE
    8NDC:51414-500-089 mL in 1 PACKAGE
    9NDC:51414-500-0910 mL in 1 PACKAGE
    10NDC:51414-500-1015 mL in 1 PACKAGE
    11NDC:51414-500-1120 mL in 1 PACKAGE
    12NDC:51414-500-1225 mL in 1 PACKAGE
    13NDC:51414-500-1330 mL in 1 PACKAGE
    14NDC:51414-500-1435 mL in 1 PACKAGE
    15NDC:51414-500-1540 mL in 1 PACKAGE
    16NDC:51414-500-1645 mL in 1 PACKAGE
    17NDC:51414-500-1750 mL in 1 PACKAGE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/12/2012
    Labeler - Yuyao Jessie Commodity Co.,Ltd. (529892305)
    Establishment
    NameAddressID/FEIBusiness Operations
    Yuyao Jessie Commodity Co.,Ltd.529892305manufacture(51414-500)
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