Label: HYVEE PRO CLEAN BLUE MINT- cetylpyridinium chloride liquid 

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: OTC monograph not final

NOTE: Most over the counter (OTC) are not reviewed and approved by the 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 09/13

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  • ACTIVE INGREDIENT

    CETYLPYRIDINIUM CHLORIDE

    PURPOSE

    ANTIGINGIVITIS/ANTIPLAQUE

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  • USES

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

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  • 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.

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  • 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. 

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  • OTHER INFORMATION

    STORE AT ROOM TEMPERATURE.

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  • INACTIVE INGREDIENTS

    WATER (AQUA), GLYCERIN, POLOXAMER 407, FLAVOR, SODIUM SACCHARIN, METHYLPARABEN, SUCRALOSE, PROPYLPARABEN, BLUE 1 (CI 42090).

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  • QUESTIONS OR COMMENTS?

    1-800-289-8343

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  • LABEL COPY
  • INGREDIENTS AND APPEARANCE
    HYVEE  PRO CLEAN BLUE MINT
    cetylpyridinium chloride liquid
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:42507-553
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETYLPYRIDINIUM CHLORIDE (CETYLPYRIDINIUM) CETYLPYRIDINIUM CHLORIDE 0.7 mg  in 1 mL
    Inactive Ingredients
    Ingredient Name Strength
    WATER  
    GLYCERIN  
    POLOXAMER 407  
    SACCHARIN SODIUM  
    METHYLPARABEN  
    SUCRALOSE  
    PROPYLPARABEN  
    FD&C BLUE NO. 1  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:42507-553-16 474 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph not final part356 09/12/2013
    Labeler - HYVEE INC. (006925671)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    Name Address ID/FEI Business Operations
    APOLLO HEALTH AND BEAUTY CARE 201901209 manufacture(42507-553)
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