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

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 under six years of age

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.

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

label

UPC 801803 00211 MEGAFRESH GEL FLUORIDE TOOTH 
sodium fluoride paste, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54157-109
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.10 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
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 CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54157-109-0117 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
2NDC:54157-109-0224 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
3NDC:54157-109-0343 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
4NDC:54157-109-0478 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
5NDC:54157-109-0585 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
6NDC:54157-109-06130 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
7NDC:54157-109-07181 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
8NDC:54157-109-08200 g in 1 TUBE; Type 0: Not a Combination Product06/03/2017
9NDC:54157-109-094.25 g in 1 POUCH; Type 0: Not a Combination Product06/03/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/03/2017
Labeler - American Amenities, Inc. (181454026)
Registrant - American Amenities, Inc. (181454026)

Revised: 6/2017
Document Id: 298788aa-35a5-48f2-acad-c2187917f047
Set id: 42824602-9b12-449d-9888-ade5a97ce129
Version: 1
Effective Time: 20170603
 
American Amenities, Inc.