GRIN- 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. Do not use if you have an allergy to bees or bee products.

Directions

For best results brush at least twice daily after meals and use in conjunction with Grin dental floss. Children 6 years and under should use a smear of toothpaste and have adult supervision until good habits are established. Do not swallow, spit out excess toothpaste.

Inactive ingredients

Calcium Carbonate, Glycerine (Palm-free from Rapeseed), Aqua (Water), Xylitol, Lauryl Glucoside (Palm-free from Coconut), Sodium Bicarbonate, Chondrus crispus (Carrageenan) Gum, Foeniculum vulgare dulce (Fennel) Extract, Spearmint Flavour, Clove Flavour, Menthol, Xanthan Gum, Peppermint Oil, Organic NZ Sea Salt, Propolis cera (Propolis) Extract

Product Label

image description

GRIN 
sodium monofluorophosphate paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:78420-002
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)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
CHONDRUS CRISPUS CARRAGEENAN (UNII: UE856F2T78)  
FOENICULUM VULGARE FRUIT (UNII: J5W36Y5WG8)  
SPEARMINT (UNII: J7I2T6IV1N)  
CLOVE (UNII: K48IKT5321)  
MENTHOL (UNII: L7T10EIP3A)  
XANTHAN GUM (UNII: TTV12P4NEE)  
PEPPERMINT OIL (UNII: AV092KU4JH)  
SEA SALT (UNII: 87GE52P74G)  
PROPOLIS WAX (UNII: 6Y8XYV2NOF)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:78420-002-01100 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: bd63a083-fc90-4bcf-8503-52cd125ce8ac
Set id: 4d9bf125-ea23-4f76-aa20-bf36185572da
Version: 1
Effective Time: 20200630
 
GRIN NATURAL PRODUCTS LIMITED