KISS MY FACE TRIPLE ACTION- sodium monofluorophosphate paste, dentifrice

Kiss My Face by

Drug Labeling and Warnings

Kiss My Face by is a Otc medication manufactured, distributed, or labeled by Kiss My Face, LLC, Lornamead Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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

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

Inactive Ingredients
Ingredient Name	Strength
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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
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 Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	08/01/2017

Labeler - Kiss My Face, LLC (041794279)

Registrant - Lornamead Inc. (078584069)

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