SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA GENTLE FORMULA- sodium fluoride paste, dentifrice

Spearmint and Peppermint PLAQUE A WAY Fluoride AnticavityGentle Formula by

Drug Labeling and Warnings

Spearmint and Peppermint PLAQUE A WAY Fluoride AnticavityGentle Formula by is a Otc medication manufactured, distributed, or labeled by SLH Optimal Health LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Spearmint and Peppermint PLAQUE A WAY Fluoride Anticavity Toothpaste Gentle Formula

Active Ingredient

Sodium fluoride 0.24% (0.14 w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

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.

Directions

• adults and children 2 years and over: Brush teeth thoroughly, preferably after each meal or at least twice a day, or as directed by a dentist or doctor.
• children under 6 years of age: 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 a supervision.
• children under 2 years of age: Consult a dentist or doctor.

Inactive Ingredients

WATER, DICALCIUM PHOSHATE, SORBITOL, GLYCERIN, SODIUM LAURYL SULFATE, ANNATTO ( BIXA ORELLANA) SEED EXTRACT, SODIUM HYDROXIDE, NATURAL AND ARTIFICIAL FLAVORS, DISODIUMM EDTA, CELLULOSE GUM, SODIUM SACCHARIN, TETRASODIUM PYROPHOSPHATE, FD AND C BLUE NO.1

Spearmint and Peppermint PLAQUE A WAY Fluoride Anticavity Toothpaste Gentle Formula 116g (

42288-000-04)

INGREDIENTS AND APPEARANCE

SPEARMINT AND PEPPERMINT PLAQUE A WAY FLUORIDE ANTICAVITYGENTLE FORMULA   GENTLE FORMULA
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 42288-000
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	SODIUM FLUORIDE	0.24 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)
SORBITOL (UNII: 506T60A25R)
GLYCERIN (UNII: PDC6A3C0OX)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
BIXA ORELLANA SEED (UNII: O87354RZ5A)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
EDETATE DISODIUM (UNII: 7FLD91C86K)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM BENZOATE (UNII: OJ245FE5EU)
SACCHARIN SODIUM DIHYDRATE (UNII: SB8ZUX40TY)
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)

Product Characteristics
Color		Score
Shape		Size
Flavor	SPEARMINT (SPEARMINT) , PEPPERMINT (PEPPERMINT)	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 42288-000-04	116 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	10/03/2012

Labeler - SLH Optimal Health LLC (031081015)

Registrant - SLH Optimal Health LLC (031081015)

Establishment
Name	Address	ID/FEI	Business Operations
SLH Optimal Health LLC		031081015	manufacture(42288-000)