KISS MY FACE KIDS BERRY SMART- 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 0.76% w/w

PURPOSE

Purpose

Anticavity

INDICATIONS & USAGE

Uses

Aids in the prevention of dental cavities

WARNINGS

Warnings

• Keep out of reach of children under 6 years of age.
• If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION

Directions

• Adults and children 6 years of age and older: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor. Instruct children over 6 years of age in good brushing and rinsing habits (to minimize swallowing). Supervise children as necessary until capable of using without supervision.
• 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: Water, Glycerin, Hydrated Silica, Xylitol, Vaccinium Macrocarpon (Cranberry) Fruit Powder, Zinc Citrate, Aloe Barbadensis Leaf Extract, Melaleuca Alternifolia (Tea Tree) Leaf Oil, Natural Flavor, Stevia Rebaudiana Extract, Cellulose Gum, Sorbic Acid

SPL UNCLASSIFIED SECTION

Dist. Kiss My Face LLC, Gardiner, NY 12525 USA

PRINCIPAL DISPLAY PANEL

KISS MY FACE®

obsessively kids®

Toothpaste with fluoride

berry smart™

no parabens, SLS, artificial colors or flavors...no kidding!

NET WT. 4 OZ (113 g)

INGREDIENTS AND APPEARANCE

KISS MY FACE  KIDS BERRY SMART
sodium monofluorophosphate paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 65364-404
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
ZINC CITRATE (UNII: K72I3DEX9B)
SORBIC ACID (UNII: X045WJ989B)
WATER (UNII: 059QF0KO0R)
TEA TREE OIL (UNII: VIF565UC2G)
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)
VACCINIUM MACROCARPON WHOLE (UNII: D11KO7O2DX)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
GLYCERIN (UNII: PDC6A3C0OX)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
XYLITOL (UNII: VCQ006KQ1E)

Product Characteristics
Color		Score
Shape		Size
Flavor	BERRY	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 65364-404-13	1 in 1 CARTON	08/01/2017
1		113 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(65364-404)