HYVEE PRO CLEAN BLUE MINT (CETYLPYRIDINIUM CHLORIDE) LIQUID [HYVEE INC.]

HYVEE PRO CLEAN BLUE MINT (CETYLPYRIDINIUM CHLORIDE) LIQUID [HYVEE INC.]
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NDC 42507-553-16
Set ID 76b1059b-abc5-44b0-92f4-fada3573ae9a
Category HUMAN OTC DRUG LABEL
Packager HYVEE INC.
Generic Name
Product Class
Product Number
Application Number PART356
  • ACTIVE INGREDIENT

    CETYLPYRIDINIUM CHLORIDE

    PURPOSE

    ANTIGINGIVITIS/ANTIPLAQUE

  • USES

    HELPS REDUCE AND PREVENT PLAQUE AND GINGIVITIS. HELPS CONTROL PLAQUE BACTERIA THAT CONTRIBUTE TO THE DEVELOPMENT OF GINGIVITIS AND BLEEDING GUMS.

  • WARNINGS

    ASK A 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.

  • 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?

    1-800-289-8343

  • LABEL COPY

    IMAGE OF THE LABEL

  • INGREDIENTS AND APPEARANCE
    HYVEE  PRO CLEAN BLUE MINT
    cetylpyridinium chloride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-553
    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:42507-553-16474 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph not finalpart35609/12/2013
    Labeler - HYVEE INC. (006925671)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-553)

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