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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:78420-002
Route of Administration	TOPICAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.76 g in 100 g

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NDC:78420-002-01	100 g in 1 TUBE; Type 0: Not a Combination Product	06/01/2020

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	06/01/2020

Labeler - GRIN NATURAL PRODUCTS LIMITED (594904384)