Kiss My Face Whitening (Sodium Monofluorophosphate) Gel, Dentifrice [Kiss My Face, Llc] -

KISS MY FACE WHITENING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [KISS MY FACE, LLC]
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NDC	65364-400-27
Set ID	822ce0f7-b8a6-6a5d-e053-2991aa0a11fb
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 0.76% w/w
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.
- 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: Sorbitol, Glycerin, Hydrated Silica, Aqua, Xylitol, Aloe Barbadensis (Aloe Vera) Leaf Extract*, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Leaf Extract, Cetraria Islandica (Iceland Moss) Extract, Stevia Rebaudiana Extract, Natural Flavor, Mentha Piperita (Peppermint) Oil, Menthol, Ammonium Glycyrrhizate (Licorice), Xanthan Gum, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Sarcosinate, Chlorophyllin-Copper Complex, Potassium Sorbate

*Organic
SPL UNCLASSIFIED SECTION

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

KISS MY FACE®

BREATH BLASTING FRESHNESS™

WHITENING ANTICAVITY FLUORIDE Toothpaste with Xylitol

WHITENS • REMOVES PLAQUE

Cool Mint Gel

Great Taste - No Triclosan/SLS

antioxidant defenders™: Iceland moss extract • tea tree oil

Net Wt. 4.5 oz (127.6 g)

INGREDIENTS AND APPEARANCE

KISS MY FACE WHITENING
sodium monofluorophosphate gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:65364-400
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
PEPPERMINT OIL (UNII: AV092KU4JH)
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)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)
XANTHAN GUM (UNII: TTV12P4NEE)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
MENTHOL (UNII: L7T10EIP3A)
CETRARIA ISLANDICA SUBSP. ISLANDICA (UNII: BJ7YPN79A1)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)
ALOE VERA LEAF (UNII: ZY81Z83H0X)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:65364-400-27	1 in 1 CARTON	03/01/2014
1		127.6 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	03/01/2014

Labeler - Kiss My Face, LLC (041794279)

Registrant - Lornamead Inc. (078584069)

Name	Address	ID/FEI	Business Operations
Establishment
Lornamead Inc.		078584069	manufacture(65364-400)

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Medic

KISS MY FACE WHITENING (SODIUM MONOFLUOROPHOSPHATE) GEL, DENTIFRICE [KISS MY FACE, LLC]

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