Label: GRIN KIDS- sodium monofluorophosphate 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 June 30, 2020

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  • Active Ingredient

    Sodium Monofluorophosphate 0.76% (1000ppm)

  • Purpose

    Anticavity

  • Use

    Aids in the prevention of dental cavities.

  • KEEP OUT OF REACH OF CHILDREN

    Keep out of reach of children under 6 years of age.

  • Warnings

    If you accidentally swallow more than used for brushing, get medical help or contact a Poison Control Center immediately.

  • Directions

    For best results brush at least twice daily  after meals. Children 6 years and under should use a smear of toothpaste and have adult supervision.
    Do not swallow, spit out excess toothpaste.

  • Inactive ingredients

    Aloe Barbadensis (Aloe Vera) Leaf Extract Organic, Aqua (Water), Calcium Carbonate, Calendula Officinalis (Calendula) Oil Organic, Chondrus Crispus (Carrageenan) Gum, Foeniculum Vulgare Dulce (Fennel) Extract, Glycerine, Lauryl Glucoside, Menthol, Natural Strawberry Flavour, Organic NZ Sea Salt, Xanthan Gum, Xylitol.

  • Product Label

    image description

  • INGREDIENTS AND APPEARANCE
    GRIN KIDS 
    sodium monofluorophosphate paste
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78420-001
    Route of AdministrationTOPICAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.76 g  in 100 g
    Inactive Ingredients
    Ingredient NameStrength
    CALCIUM CARBONATE (UNII: H0G9379FGK)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    WATER (UNII: 059QF0KO0R)  
    XYLITOL (UNII: VCQ006KQ1E)  
    LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)  
    ALOE VERA LEAF (UNII: ZY81Z83H0X)  
    CALENDULA OFFICINALIS SEED OIL (UNII: 9JS8DS42SV)  
    CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
    FOENICULUM VULGARE FRUIT (UNII: J5W36Y5WG8)  
    SEA SALT (UNII: 87GE52P74G)  
    MENTHOL (UNII: L7T10EIP3A)  
    XANTHAN GUM (UNII: TTV12P4NEE)  
    STRAWBERRY (UNII: 4J2TY8Y81V)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:78420-001-0170 g in 1 TUBE; Type 0: Not a Combination Product06/01/2020
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    OTC monograph finalpart35506/01/2020
    Labeler - GRIN NATURAL PRODUCTS LIMITED (594904384)
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