MEGAFRESH- sodium fluoride gel, dentifrice 
American Amenities, Inc.

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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Active Ingredient: Sodium Fluoride (0.243%)

Purpose: Anticavity

Uses: Aids in the prevention of dental cavities

For external use only. Keep out of reach of children

Keep out of reach of children under six years of age

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

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.

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

label

MEGAFRESH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54157-104
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54157-104-0117 g in 1 TUBE
2NDC:54157-104-0224 g in 1 TUBE
3NDC:54157-104-0335 g in 1 TUBE
4NDC:54157-104-0443 g in 1 TUBE
5NDC:54157-104-0550 g in 1 TUBE
6NDC:54157-104-0670 g in 1 TUBE
7NDC:54157-104-0778 g in 1 TUBE
8NDC:54157-104-0890 g in 1 TUBE
9NDC:54157-104-09100 g in 1 TUBE
10NDC:54157-104-10120 g in 1 TUBE
11NDC:54157-104-11130 g in 1 TUBE
12NDC:54157-104-12150 g in 1 TUBE
13NDC:54157-104-13181 g in 1 TUBE
14NDC:54157-104-14200 g in 1 TUBE
15NDC:54157-104-154.25 g in 1 POUCH
16NDC:54157-104-163 g in 1 POUCH
17NDC:54157-104-175 g in 1 POUCH
18NDC:54157-104-1810 g in 1 POUCH
19NDC:54157-104-1971 g in 1 TUBE
20NDC:54157-104-2085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35505/11/2014
Labeler - American Amenities, Inc. (181454026)
Registrant - American Amenities, Inc. (181454026)

Revised: 1/2015
Document Id: b64481d2-6ade-4eeb-b267-667e1085f1c0
Set id: 803ebf8d-32bd-4060-b51b-88fca0a5ccee
Version: 3
Effective Time: 20150116
 
American Amenities, Inc.