OTC Medication Information: MyntSmile DIAMYNT

MYNTSMILE DIAMYNT- sodium monofluorophosphate paste, dentifrice
LMKAO LLC

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.

Active Ingredient:

Sodium Monofluorophosphate 0.83% w/w

Purpose:

Anti cavity toothpaste.

Uses:

Aids in the prevention of dental cavities.

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.

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 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

Questions: 1-855-MYNT-SMILE

www.myntsmile.com

PATENT PENDING FORMULA

Distributed by:

LMKAO LLC, New York, NY

10006 Made in USA

DIAMYNT TUBE LABEL

DIAMYNT TUBE LABEL
(click image for full-size original)

DIAMYNT BOX LABEL

DIAMYNT BOX LABEL
(click image for full-size original)
MYNTSMILE DIAMYNT
sodium monofluorophosphate paste, dentifrice
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:42357-001
Route of Administration DENTAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
SODIUM MONOFLUOROPHOSPHATE (FLUORIDE ION) SODIUM MONOFLUOROPHOSPHATE 0.83 g in 100 g
Inactive Ingredients
Ingredient Name Strength
WATER
GLYCERIN
HYDRATED SILICA
GLYCERIN
ALUMINUM OXIDE
HYDRATED SILICA
SORBITOL
XANTHAN GUM
TITANIUM DIOXIDE
COCAMIDOPROPYL BETAINE
XYLITOL
ALOE VERA LEAF
MENTHA PIPERITA
SAGE
CHAMOMILE FLOWER OIL
DIAMOND
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42357-001-01 1 TUBE (TUBE) in 1 BOX contains a TUBE
1 112 g in 1 TUBE This package is contained within the BOX (42357-001-01)
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)

Revised: 03/2012 LMKAO LLC

Our database comes directly from the FDA’s central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA’s repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

Our database comes directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. OTCLabels.com provides the full over the counter products subset of the FDA's repository. Medication information provided here is not intended as a substitute for direct consultation with a qualified health professional.

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