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MegaFresh by American Amenities, Inc.

Dosage form: gel, dentifrice
Ingredients: SODIUM FLUORIDE 0.10g in 100g
Labeler: American Amenities, Inc.
NDC Code: 54157-102

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.

Active Ingredient: Sodium Fluoride (0.22%)

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

MEGAFRESH 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54157-102
Route of AdministrationDENTALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION0.10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
WATER 
SORBITOL 
POLYETHYLENE GLYCOL 1500 
CARBOXYMETHYLCELLULOSE SODIUM 
SODIUM LAURYL SULFATE 
CARBOMER HOMOPOLYMER TYPE C 
HYDRATED SILICA 
SACCHARIN SODIUM 
METHYLPARABEN 
PROPYLPARABEN 
Packaging
#Item CodePackage Description
1NDC:54157-102-0117 g in 1 TUBE
2NDC:54157-102-0224 g in 1 TUBE
3NDC:54157-102-0335 g in 1 TUBE
4NDC:54157-102-0443 g in 1 TUBE
5NDC:54157-102-0550 g in 1 TUBE
6NDC:54157-102-0670 g in 1 TUBE
7NDC:54157-102-0778 g in 1 TUBE
8NDC:54157-102-0890 g in 1 TUBE
9NDC:54157-102-09100 g in 1 TUBE
10NDC:54157-102-10120 g in 1 TUBE
11NDC:54157-102-11130 g in 1 TUBE
12NDC:54157-102-12150 g in 1 TUBE
13NDC:54157-102-13181 g in 1 TUBE
14NDC:54157-102-14200 g in 1 TUBE
15NDC:54157-102-154.25 g in 1 POUCH
16NDC:54157-102-163 g in 1 POUCH
17NDC:54157-102-175 g in 1 POUCH
18NDC:54157-102-1810 g in 1 POUCH
19NDC:54157-102-1971 g in 1 TUBE
20NDC:54157-102-2085 g in 1 TUBE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35511/04/2013
Labeler - American Amenities, Inc. (181454026)
Registrant - American Amenities, Inc. (181454026)

Revised: 01/2015
 
American Amenities, Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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