QUALITY CHOICE MINT (CETYLPRYIDINIUM CHLORIDE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC]

QUALITY CHOICE MINT (CETYLPRYIDINIUM CHLORIDE) LIQUID [CHAIN DRUG MARKETING ASSOCIATION INC]
PDF | XML

NDC 63868-553-33
Set ID beb24f57-87d5-4c86-9de4-09766ccc57d9
Category HUMAN OTC DRUG LABEL
Packager CHAIN DRUG MARKETING ASSOCIATION INC
Generic Name
Product Class
Product Number
Application Number PART356
  • Active ingredients

    Cetylpyridinium Chloride 0.07%

    Purpose

    Antiplaque/Antigingivitis

  • Uses

    • Helps reduce and prevent plaque and gingivitis.
    • Helps control plaque bacteria that contribute to the development of gingivitis and bleeding gums.
  • Warnings

    Ask dentist if symptoms persist or condition worsens after regular use.

    Keep out of reach of children under 6 years of age.

    If more than used for rinsing is accidentally swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222)

  • Directions

    • Use after your normal brushing and flossing routine; rinse toothpaste from mouth prior to use
    • Adults and children 6 years and older: Rinse for 30 seconds with 20 mL (4 teaspoonfuls) twice a day.
    • Do not swallow
    • Children 6 years to under 12 years of age: supervise use
    • Children under 6 years of age: do not use.
  • Other information

    Store at room temperature

  • Inactive ingredients

    Water (Aqua), Glycerin, Poloxamer 407, Flavor, Sodium Saccharin, Methylparaben, Sucralose, Propylparaben, Blue 1 (CI 42090)

  • Questions or comments?

    1-248-449-9300

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    QUALITY CHOICE MINT 
    cetylpryidinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-553
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETYLPYRIDINIUM CHLORIDE (UNII: D9OM4SK49P) (CETYLPYRIDINIUM - UNII:CUB7JI0JV3) CETYLPYRIDINIUM CHLORIDE0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-553-331000 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/13/2015
    Labeler - CHAIN DRUG MARKETING ASSOCIATION INC (011920774)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(63868-553)

Related Drugs