Label: NAVI BLACK AND C-CLINIC- calcium carbonate aminocaproic acid aluminum chlorohydroxy allantoinate dibasic calcium phosphate paste

  • 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 April 2, 2013

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  • ACTIVE INGREDIENT

    Active Ingredients: Calcium Carbonate 40%, Aminocaproic Acid 0.1%, Aluminum Chlorohydroxy Allantoinate 0.1%, Dibasic Calcium Phosphate 0.8%

  • PURPOSE

    Purpose: Anticavity

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years old

  • INDICATIONS & USAGE

    - Supervise children as necessary until being capable of using without supervision

    - Instruct children under 6 years old in good brushing and rinsing habits

  • WARNINGS

    If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away

  • INACTIVE INGREDIENT

    Inactive Ingredients: Xylitol, Erythritol, D-Sorbitol Solution, L-Menthol, Peppermint Oil, Medicinal Carbon

  • DOSAGE & ADMINISTRATION

    - Brush teeth twice daily or after each meal as directed by a dentist or doctor

  • PRINCIPAL DISPLAY PANEL

    Box Label

  • INGREDIENTS AND APPEARANCE
    NAVI BLACK AND C-CLINIC 
    calcium carbonate aminocaproic acid aluminum chlorohydroxy allantoinate dibasic calcium phosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55526-0005
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION48 g  in 120 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID0.12 g  in 120 g
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) ANHYDROUS DIBASIC CALCIUM PHOSPHATE0.12 g  in 120 g
    Inactive Ingredients
    Ingredient NameStrength
    XYLITOL (UNII: VCQ006KQ1E)  
    ERYTHRITOL (UNII: RA96B954X6)  
    SORBITOL (UNII: 506T60A25R)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55526-0005-1120 g in 1 TUBE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart33104/01/2013
    Labeler - EQ Maxon Corp. (557821534)
    Establishment
    NameAddressID/FEIBusiness Operations
    EQ Maxon Corp.557821534manufacture(55526-0005)