Label: CINNAFRESH ANTICAVITY- sodium fluoride gel, dentifrice

  • 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 August 15, 2019

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  • ACTIVE INGREDIENT

    Sodium Fluoride - 0.22% (0.1% w/v fluoride ion)

    DRUG FACTS

  • PURPOSE

    Anticavity Toothpaste.

  • USE

    Helps protect against cavities.

  • WARNINGS

    Keep out of reach of children under 6 years of age. If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center immediately.

  • DIRECTIONS:

    Adults & Children 6 years of age & older : Brush teeth throughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

    Children 2 to 6 years : Use only a pea sized amount and supervise child's brushing and rinsing (to minimize swallowing).

    Children under 2 years : Ask a dentist or physician.

  • INACTIVE INGREDIENTS:

    Purified Water, Sorbitol, Sodium Lauryl Sulphate, Carbopol, Flavor, Sodium Hydroxide, Sodium Saccharin, Ethylene Diamine Tetra Acetic Acid, Kathon CG, Ponceu 4R.

  • PRINCIPAL DISPLAY PANEL - 24 g Tube

    Display Panel

  • INGREDIENTS AND APPEARANCE
    CINNAFRESH ANTICAVITY 
    sodium fluoride gel, dentifrice
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76001-003
    Route of AdministrationDENTAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.22 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    PONCEAU 4R (UNII: Z525CBK9PG)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    WATER (UNII: 059QF0KO0R)  
    SORBITOL (UNII: 506T60A25R)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
    CARBOMER HOMOPOLYMER, UNSPECIFIED TYPE (UNII: 0A5MM307FC)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    EDETATE DISODIUM (UNII: 7FLD91C86K)  
    METHYLCHLOROISOTHIAZOLINONE/METHYLISOTHIAZOLINONE MIXTURE (UNII: 15O9QS218W)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:76001-003-0124 g in 1 TUBE; Type 0: Not a Combination Product01/01/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35501/01/2018
    Labeler - Daxal Cosmetics Private Limited (650497790)
    Establishment
    NameAddressID/FEIBusiness Operations
    Daxal Cosmetics Private Limited650497790manufacture(76001-003)
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