MEGAFRESH- sodium fluoride gel, dentifrice

MegaFresh by

Drug Labeling and Warnings

MegaFresh 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 (0.22%)

PURPOSE

Purpose: Anticavity

INDICATIONS & USAGE

Uses: Aids in the prevention of dental cavities

WARNINGS

For external use only. Keep out of reach of children

KEEP OUT OF REACH OF CHILDREN

Keep out of reach of children under six years of age

ASK DOCTOR

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

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

Purified Water,Sorbitol, Polyethylene Glycol 1500, Carboxymethylcellulose Sodium, Sodium Lauryl Sulfate, Flavour, Carbomer Homopolymer Type C, Hydrated Silica, Saccharin Sodium,Methylparaben, Propylparaben

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

MEGAFRESH 
sodium fluoride gel, dentifrice

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 54157-102
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)
SORBITOL (UNII: 506T60A25R)
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)
SODIUM LAURYL SULFATE (UNII: 368GB5141J)
CARBOMER HOMOPOLYMER TYPE C (UNII: 4Q93RCW27E)
HYDRATED SILICA (UNII: Y6O7T4G8P9)
SACCHARIN SODIUM (UNII: SB8ZUX40TY)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 54157-102-01	17 g in 1 TUBE
2	NDC: 54157-102-02	24 g in 1 TUBE
3	NDC: 54157-102-03	35 g in 1 TUBE
4	NDC: 54157-102-04	43 g in 1 TUBE
5	NDC: 54157-102-05	50 g in 1 TUBE
6	NDC: 54157-102-06	70 g in 1 TUBE
7	NDC: 54157-102-07	78 g in 1 TUBE
8	NDC: 54157-102-08	90 g in 1 TUBE
9	NDC: 54157-102-09	100 g in 1 TUBE
10	NDC: 54157-102-10	120 g in 1 TUBE
11	NDC: 54157-102-11	130 g in 1 TUBE
12	NDC: 54157-102-12	150 g in 1 TUBE
13	NDC: 54157-102-13	181 g in 1 TUBE
14	NDC: 54157-102-14	200 g in 1 TUBE
15	NDC: 54157-102-15	4.25 g in 1 POUCH
16	NDC: 54157-102-16	3 g in 1 POUCH
17	NDC: 54157-102-17	5 g in 1 POUCH
18	NDC: 54157-102-18	10 g in 1 POUCH
19	NDC: 54157-102-19	71 g in 1 TUBE
20	NDC: 54157-102-20	85 g in 1 TUBE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph final	part355	11/04/2013

Labeler - American Amenities, Inc. (181454026)

Registrant - American Amenities, Inc. (181454026)