GRIN KIDS- sodium monofluorophosphate paste 
GRIN NATURAL PRODUCTS LIMITED

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.

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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 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

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)

Revised: 6/2020
Document Id: fa4c81b0-701f-4896-bc93-99c85b8cb78d
Set id: beb25ece-940a-4f9d-bf59-19798646bf44
Version: 1
Effective Time: 20200630
 
GRIN NATURAL PRODUCTS LIMITED