UPC 801803 00211 MEGAFRESH GEL FLUORIDE TOOTH- sodium fluoride paste, dentifrice

UPC 801803 00211 MegaFresh Gel Fluoride Tooth by

Drug Labeling and Warnings

UPC 801803 00211 MegaFresh Gel Fluoride Tooth by is a Otc medication manufactured, distributed, or labeled by American Amenities, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

ACTIVE INGREDIENT

Active Ingredient: Sodium Fluoride (0.243%)

PURPOSE

Purpose: Anticavity

INDICATIONS & USAGE

Uses: Aids in the prevention of dental cavities

WARNINGS

If more than used for brushing is accidentally swallowed, get medical help or contact a poison control center immediately.

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under six years of age

DOSAGE & ADMINISTRATION

Adults and children of two years of age and older: Brush teeth thoroughly, perferrably after each meal or at least twice a day, or as directed by a dentist or a doctor. Instruct children under six years of age in good brushing and rinsing habit (to minimize swollowing). Supervise children as necessary until capable of using without supervision. Children under 2 years of age: consult a dentist or doctor.

INACTIVE INGREDIENT

Sorbitol, Hydrated Silica, Glycerin, Purified Water, Polyethylene Glycol, Sodium Lauryl Sulfate,  Carboxymethylcellulose Sodium, Flavor, Xanthan Gum, Saccharin Sodium, Methylisothiazolinone

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

UPC 801803 00211 MEGAFRESH GEL FLUORIDE TOOTH 
sodium fluoride paste, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54157-109
Route of Administration	DENTAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.10 g  in 100 g

Inactive Ingredients
Ingredient Name	Strength
WATER (UNII: 059QF0KO0R)
GLYCERIN (UNII: PDC6A3C0OX)
SORBITOL (UNII: 506T60A25R)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
XANTHAN GUM (UNII: TTV12P4NEE)
METHYLISOTHIAZOLINONE (UNII: 229D0E1QFA)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54157-109-01	17 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
2	NDC: 54157-109-02	24 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
3	NDC: 54157-109-03	43 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
4	NDC: 54157-109-04	78 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
5	NDC: 54157-109-05	85 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
6	NDC: 54157-109-06	130 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
7	NDC: 54157-109-07	181 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
8	NDC: 54157-109-08	200 g in 1 TUBE; Type 0: Not a Combination Product	06/03/2017
9	NDC: 54157-109-09	4.25 g in 1 POUCH; Type 0: Not a Combination Product	06/03/2017

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	06/03/2017

Labeler - American Amenities, Inc. (181454026)

Registrant - American Amenities, Inc. (181454026)