Label: HYVEE COMPLETE CARE FRESH MINT- sodium fluoride 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 November 27, 2015

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  • Active Ingredient

    Sodium Fluoride 0.02% (0.01% w/v Fluoride ion)

    Purpose

    Antigingivitis/Antiplaque

  • Uses

    to help reduce and prevent

    • plaque
    • gingivitis
  • Warnings

    Do not use in children under 12 years of age

    Keep out of reach of children

    If more than used for rinsing is accidentally ingested, get medical help or contact a Poison Control Center immediately

  • Directions

    • Rinse full strength for 30 seconds with 20 mL (2/3 fluid ounce or 4 teaspoonfuls) morning and night
    • Do not swallow
  • Other information

    • Store at room temperature
    • Cold weather may cloud this product. Its antiseptic properties are not affected.
  • Inactive ingredients

    Water (Aqua), Sorbitol, Alcohol (21.6%), Poloxamer 407, Sodium Lauryl Sulfate, Eucalyptol, Flavor, Methyl Salicylate, Thymol, Phosphoric Acid, Sucralose, Menthol, Disodium Phosphate, Red 40 (CI 16035), Blue 1 (CI 42090).

  • Questions or comments?

    1-800-289-8343

  • Label Copy

    Image of the label

  • INGREDIENTS AND APPEARANCE
    HYVEE  COMPLETE CARE FRESH MINT
    sodium fluoride liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:42507-552
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.2 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    ALCOHOL (UNII: 3K9958V90M)  
    POLOXAMER 407 (UNII: TUF2IVW3M2)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    EUCALYPTOL (UNII: RV6J6604TK)  
    METHYL SALICYLATE (UNII: LAV5U5022Y)  
    THYMOL (UNII: 3J50XA376E)  
    PHOSPHORIC ACID (UNII: E4GA8884NN)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MENTHOL (UNII: L7T10EIP3A)  
    SODIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: 22ADO53M6F)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:42507-552-331000 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 finalpart35509/12/2013
    Labeler - HYVEE INC. (006925671)
    Registrant - APOLLO HEALTH AND BEAUTY CARE (201901209)
    Establishment
    NameAddressID/FEIBusiness Operations
    APOLLO HEALTH AND BEAUTY CARE201901209manufacture(42507-552)
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