SPRY DENTIFRICE- toothpaste paste, dentifrice

Spry Dentifrice by

Drug Labeling and Warnings

Spry Dentifrice by is a Otc medication manufactured, distributed, or labeled by Xlear Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

KEEP OUT OF REACH OF CHILDREN

Warning: keep out of reach of children under 6 years of age.

WARNINGS AND PRECAUTIONS

Warnings: If more than used for brushing is accidentaly swallowed, get medical help or contact poison control center right away.

STOP USE

Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

INDICATIONS & USAGE

Directions: Adults and children two years 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 under 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 2 years of age: consult a dentist or doctor.

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 poison control center right away

ACTIVE INGREDIENT

Sodium fluoride 0.243% (w/w)

Anticavity toothpaste

PURPOSE

Aids in the prevention of dental cavities

Anticavity Toothpaste

DOSAGE & ADMINISTRATION

Directions: adults and children two years and older:

brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.

INACTIVE INGREDIENT

Water, silica, vegetable glycerin, xylitol, erythritol, lauryl glucoside, L-arginine, sodium methyl cocoyl taurate, natural speramint flavor, cranberry extract, xanthan gum, titanium dioxide, stevia, cellulose gum, sodium trimetaphosphate, sodium benzoate, zinc citrate, aloe vera

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

SPRY DENTIFRICE 
toothpaste paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 27017-142
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	2.43 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
ZINC CITRATE (UNII: K72I3DEX9B)
ALOE VERA LEAF (UNII: ZY81Z83H0X)
CELLULOSE GUM (UNII: K679OBS311)
GLYCERIN (UNII: PDC6A3C0OX)
STEVIA LEAF (UNII: 6TC6NN0876)
ERYTHRITOL (UNII: RA96B954X6)
LAURYL GLUCOSIDE (UNII: 76LN7P7UCU)
SODIUM METHYL COCOYL TAURATE (UNII: JVL98CG53G)
WATER (UNII: 059QF0KO0R)
SODIUM BENZOATE (UNII: OJ245FE5EU)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
N2-(4-FLUOROBENZOYL)-L-ARGININE (UNII: NN7Q1D14KA)
SPEARMINT OIL (UNII: C3M81465G5)
XANTHAN GUM (UNII: TTV12P4NEE)
SODIUM TRIMETAPHOSPHATE (UNII: 3IH6169RL0)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
XYLITOL (UNII: VCQ006KQ1E)
CRANBERRY (UNII: 0MVO31Q3QS)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 27017-142-01	1 g in 1 TUBE; Type 0: Not a Combination Product	06/11/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC Monograph Drug	M021	06/11/2017

Labeler - Xlear Inc. (839884058)

Registrant - Xlear Inc. (839884058)

Establishment
Name	Address	ID/FEI	Business Operations
Xlear Inc.		839884058	manufacture(27017-142)