MYNTSMILE DIAMYNT- sodium monofluorophosphate paste, dentifrice

MyntSmile by

Drug Labeling and Warnings

MyntSmile by is a Otc medication manufactured, distributed, or labeled by LMKAO LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient:

Sodium Monofluorophosphate 0.83% w/w

PURPOSE

Purpose:

Anti cavity toothpaste.

INDICATIONS & USAGE

Uses:

Aids in the prevention of dental cavities.

WARNINGS

Warnings:

As with all fluoride toothpastes, Keep out of reach of children under 6 yrs of age.

If you accidentally swallow more than used for brushing, get medical help or contact a poison control center right away.

KEEP OUT OF REACH OF CHILDREN

DOSAGE & ADMINISTRATION

Directions

For best results: Brush teeth thoroughly after each meal, at least twice a day, or as directed by a dentist. Instruct children under six about good brushing and rinsing habits to minimize swallowing.

Supervise children as necessary until capable of using without supervision. Under two years of age consult a dentist or a doctor before use.

INACTIVE INGREDIENT

Inactive ingredients:

Water, Glycerin, Hydrated Silica, Sorbitol, Xanthan Gum, Titanium Dioxide, Flavor, Cocamidopropyl Betaine, Xylitol, Aloe Barbadensis Leaf Juice, Mentha Piperita (Peppermint) Leaf Extract, Salvia Officinalis (Sage) Leaf Extract, Chamomilla Recutita (Matricaria) Flower Extarct, Diamond Powder

SPL UNCLASSIFIED SECTION

Questions: 1-855-MYNT-SMILE

www.myntsmile.com

PATENT PENDING FORMULA

Distributed by:

LMKAO LLC, New York, NY

10006 Made in USA

PRINCIPAL DISPLAY PANEL

DIAMYNT TUBE LABEL

PRINCIPAL DISPLAY PANEL

DIAMYNT BOX LABEL

INGREDIENTS AND APPEARANCE

MYNTSMILE  DIAMYNT
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42357-001
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM MONOFLUOROPHOSPHATE (UNII: C810JCZ56Q) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM MONOFLUOROPHOSPHATE	0.83 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
GLYCERIN (UNII: PDC6A3C0OX)
ALUMINUM OXIDE (UNII: LMI26O6933)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SORBITOL (UNII: 506T60A25R)
XANTHAN GUM (UNII: TTV12P4NEE)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
COCAMIDOPROPYL BETAINE (UNII: 5OCF3O11KX)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
SAGE (UNII: 065C5D077J)
CHAMOMILE FLOWER OIL (UNII: 60F80Z61A9)
DIAMOND (UNII: 6GRV67N0U2)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42357-001-01	1 in 1 BOX
1		112 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	03/10/2012

Labeler - LMKAO LLC (078346159)