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%

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  • PURPOSE

    Purpose: Anticavity

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  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years old

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  • 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

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  • WARNINGS

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

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  • INACTIVE INGREDIENT

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

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  • DOSAGE & ADMINISTRATION

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

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  • INGREDIENTS AND APPEARANCE
    NAVI BLACK AND C-CLINIC 
    calcium carbonate aminocaproic acid aluminum chlorohydroxy allantoinate dibasic calcium phosphate paste
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:55526-0005
    Route of Administration DENTAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 48 g  in 120 g
    AMINOCAPROIC ACID (UNII: U6F3787206) (AMINOCAPROIC ACID - UNII:U6F3787206) AMINOCAPROIC ACID 0.12 g  in 120 g
    DIBASIC CALCIUM PHOSPHATE DIHYDRATE (UNII: O7TSZ97GEP) (ANHYDROUS DIBASIC CALCIUM PHOSPHATE - UNII:L11K75P92J) ANHYDROUS DIBASIC CALCIUM PHOSPHATE 0.12 g  in 120 g
    Inactive Ingredients
    Ingredient Name Strength
    XYLITOL (UNII: VCQ006KQ1E)  
    ERYTHRITOL (UNII: RA96B954X6)  
    SORBITOL (UNII: 506T60A25R)  
    LEVOMENTHOL (UNII: BZ1R15MTK7)  
    PEPPERMINT OIL (UNII: AV092KU4JH)  
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:55526-0005-1 120 g in 1 TUBE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    OTC monograph final part331 04/01/2013
    Labeler - EQ Maxon Corp. (557821534)
    Establishment
    Name Address ID/FEI Business Operations
    EQ Maxon Corp. 557821534 manufacture(55526-0005)
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