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

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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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)

PlaqueAWayFrontLabel

PlaqueAWayBackLabel

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

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

Ingredient Name	Strength
Inactive Ingredients
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

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

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

Labeler - SLH Optimal Health LLC (031081015)

Registrant - SLH Optimal Health LLC (031081015)

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