Kiss My Face Triple Action (Sodium Monofluorophosphate) Paste, Dentifrice [Kiss My Face, Llc] -

KISS MY FACE TRIPLE ACTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [KISS MY FACE, LLC]
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NDC	65364-402-16
Set ID	82537fd4-c879-bb38-e053-2a91aa0a30ac
Category	HUMAN OTC DRUG LABEL
Packager	Kiss My Face, LLC
Generic Name
Product Class
Product Number
Application Number	PART355

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SPL UNCLASSIFIED SECTION

Drug Facts
ACTIVE INGREDIENT

Active ingredient

Sodium Monofluorphosphate 0.15% w/w fluoride ion
PURPOSE

Purpose

Anticavity
INDICATIONS & USAGE
Uses

Aids in the prevention of
- dental cavities
- plaque and tartar build-up
WARNINGS
Warnings
- Keep out of reach of children under 6 years of age.
- If you accidentally swallow more than used for brushing, contact a Poison Control Center or seek professional assistance immediately.
DOSAGE & ADMINISTRATION
Directions
- Apply at least a 1 inch strip of the product onto a soft bristle toothbrush. Brush teeth thoroughly for at least 1 minute twice a day or as recommended by a dentist or doctor.
- Children under 6 years of age: consult a dentist or doctor
OTHER SAFETY INFORMATION

Other information

You may report a serious adverse event from using this product to Kiss My Face, LLC, 144 Main Street, Gardiner, NY 12525.
INACTIVE INGREDIENT

Inactive ingredients Glycerin, Aqua, Hydrated Silica, Sorbitol, Xylitol, Calcium Carbonate, Olea Europaea (Olive) Leaf Extract, Cetraria Islandica (Iceland Moss) Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Stevia Rebaudiana Extract, Natural Flavor, Xanthan Gum, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Sarcosinate, Titanium Dioxide, Zinc Citrate, Potassium Sorbate
SPL UNCLASSIFIED SECTION

Dist. Kiss My Face LLC, Gardiner, NY 12525 USA
PRINCIPAL DISPLAY PANEL

KISS MY FACE®

BREATH BLASTING FRESHNESS™

TRIPLE ACTION ANTICAVITY FLUORIDE Toothpaste with Xylitol

REMOVES PLAQUE • WHITENS • PREVENTS TARTAR BUILD-UP

Fresh Mint Paste

Great Taste - No Triclosan/SLS

antioxidant defenders™: tea tree oil • olive leaf extract

Net Wt.. 4.1 oz (116.2 g)

INGREDIENTS AND APPEARANCE

KISS MY FACE TRIPLE ACTION
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65364-402
Route of Administration	DENTAL

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
SORBITOL (UNII: 506T60A25R)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
SODIUM LAUROYL SARCOSINATE (UNII: 632GS99618)
XANTHAN GUM (UNII: TTV12P4NEE)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
CALCIUM CARBONATE (UNII: H0G9379FGK)
ZINC CITRATE (UNII: K72I3DEX9B)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65364-402-16	1 in 1 CARTON	08/01/2017
1		116.2 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part355	08/01/2017

Labeler - Kiss My Face, LLC (041794279)

Registrant - Lornamead Inc. (078584069)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		078584069	manufacture(65364-402)

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Medic

KISS MY FACE TRIPLE ACTION (SODIUM MONOFLUOROPHOSPHATE) PASTE, DENTIFRICE [KISS MY FACE, LLC]

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