KISS MY FACE ENAMEL EXTRA- potassium nitrate, sodium fluoride gel, 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

Potassium Nitrate 5.0% w/w

Sodium Fluoride 0.243% w/w

PURPOSE

Purpose

Antihypersensitivity

Anticavity

INDICATIONS & USAGE

Uses

• Builds increasing protection against painful due to cold, heat, acids, sweets or contact.
• Aids in the prevention of plaque and tarter build-up.

WARNINGS

Warnings

• Sensitive teeth may indicate a serious problem that may need prompt care by a dentist. See your dentist if the problem persists or worsens.

• 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 one minute, preferably after each meal or at least 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 St, Gardiner NY 12525.

INACTIVE INGREDIENT

Inactive ingredients Glycerin, Water, Sorbitol, Hydrated Silica, Xylitol, Calcium Glycerophosphate, Aloe Barbadensis (Aloe Vera) Leaf Extract*, Aesculus Hippocastanum (Horse Chestnut) Seed Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Olea Europaea (Olive) Leaf Extract, Stevia Rebaudiana Extract, Natural Flavor, Mentha Piperita (Peppermint) Oil, Menthol, Ammonium Glycyrrhizate (Licorice) Root Extract, Xanthan Gum, Cellulose Gum, Sodium Methyl Cocoyl Taurate, Sodium Lauroyl Saracosinate, Chlorophyllin-Copper Complex, Potassium Sorbate

SPL UNCLASSIFIED SECTION

Dist: Kiss My Face LLC

Gardiner, NY 12525 USA

PRINCIPAL DISPLAY PANEL

KISS MY FACE

BREATH BLASTING FRESHNESS

ENAMEL EXTRA

ANTICAVITY FLUORIDE Toothpaste with Xylitol

Cool Mint Gel

HELPS REHARDEN ENAMEL WHITENS REDUCES SENSITIVITY

antioxidant defenders™: tea tree oil olive leaf extract

Net Wt. 4.5 oz (127.6 g)

INGREDIENTS AND APPEARANCE

KISS MY FACE  ENAMEL EXTRA
potassium nitrate, sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65364-403
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844)	POTASSIUM NITRATE	5 g  in 100 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.243 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
CALCIUM GLYCEROPHOSPHATE (UNII: XWV9Z12C1C)
WATER (UNII: 059QF0KO0R)
SODIUM LAURYL SARCOSINATE (UNII: 5PGH842FAU)
SORBITOL (UNII: 506T60A25R)
AESCULUS HIPPOCASTANUM SEED OIL (UNII: E0M52HIR1Y)
TEA TREE OIL (UNII: VIF565UC2G)
GLYCERIN (UNII: PDC6A3C0OX)
XANTHAN GUM (UNII: TTV12P4NEE)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
OLEA EUROPAEA LEAF (UNII: MJ95C3OH47)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
MENTHOL (UNII: L7T10EIP3A)
POTASSIUM SORBATE (UNII: 1VPU26JZZ4)
XYLITOL (UNII: VCQ006KQ1E)
SODIUM COPPER CHLOROPHYLLIN (UNII: 1D276TYV9O)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
MENTHA PIPERITA (UNII: 79M2M2UDA9)
AMMONIUM GLYCYRRHIZATE (UNII: 3VRD35U26C)

Product Characteristics
Color		Score
Shape		Size
Flavor	MINT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65364-403-27	1 in 1 CARTON	04/01/2015
1		127.6 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 not final	part356	04/01/2015

Labeler - Kiss My Face, LLC (041794279)

Registrant - Lornamead Inc. (078584069)

Establishment
Name	Address	ID/FEI	Business Operations
Lornamead Inc.		078584069	manufacture(65364-403)