NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE WHITE GRAPE- sodium fluoride rinse 
NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE RASPBERRY SPLASH- sodium fluoride rinse 
NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE REFRESHMINT- sodium fluoride rinse 
Germiphene Corporation

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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Neutrarinse

Recommended use:

For topical application to aid in the prevention of dental caries.

Neutral pH makes Neutrarinse especially safe for crowns and restorations.

Medicinal ingredient:

2.0% Neutral sodium fluoride

Non-medicinal ingredients:

Water, sodium phosphate dibasic, parabens, sorbitol, xylitol, sodium saccharin, ethanol, povidone, and flavouring agents.

Directions:

Dispense up to 10 mL of Neutrarinse 2% Neutral Sodium Fluoride Solution into a measuring cup. Instruct patient to rinse vigorously for one minute with up to 10 mL of the solution arond and between teeth, then expectorate. DO NOT SWALLOW. Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes.

Neutrarinse 2% Neutral Sodium Fluoride Solution may also be applied full strength with cotton pledgets, to teeth isolated with cotton rolls.

Warning:

The product is intended for topical use only, not for internal use. Not recommended for use by children under 6 years of age.

Instruct patient not to eat, drink, or rinse mouth for at least 30 minutes. Do not use if tamper-evident seal is broken. Do not store in direct sunlight.

Keep out of reach of children.

White GrapeRefreshMintRaspberry Splash

NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE WHITE GRAPE 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0527
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 1 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.052 g  in 100 g
POVIDONE (UNII: FZ989GH94E) 0.3 g  in 100 g
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) 0.043 g  in 100 g
SORBITOL (UNII: 506T60A25R) 15 g  in 100 g
WATER (UNII: 059QF0KO0R) 76.4 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E) 5 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.01 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.01 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorGRAPEImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0527-12000 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/06/2017
NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE RASPBERRY SPLASH 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0528
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 1 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.052 g  in 100 g
POVIDONE (UNII: FZ989GH94E) 0.3 g  in 100 g
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) 0.043 g  in 100 g
SORBITOL (UNII: 506T60A25R) 15 g  in 100 g
WATER (UNII: 059QF0KO0R) 76.4 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E) 5 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.01 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.01 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorBERRYImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0528-12000 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/06/2017
NEUTRARINSE 2% NEUTRAL SODIUM FLORIDE ORAL RINSE REFRESHMINT 
sodium fluoride rinse
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:61508-0526
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION2 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
ALCOHOL (UNII: 3K9958V90M) 1 g  in 100 g
METHYLPARABEN (UNII: A2I8C7HI9T) 0.052 g  in 100 g
POVIDONE (UNII: FZ989GH94E) 0.3 g  in 100 g
SODIUM PHOSPHATE, DIBASIC (UNII: GR686LBA74) 0.043 g  in 100 g
SORBITOL (UNII: 506T60A25R) 15 g  in 100 g
WATER (UNII: 059QF0KO0R) 76.4 g  in 100 g
XYLITOL (UNII: VCQ006KQ1E) 5 g  in 100 g
SACCHARIN SODIUM (UNII: SB8ZUX40TY) 0.01 g  in 100 g
PROPYLPARABEN (UNII: Z8IX2SC1OH) 0.01 g  in 100 g
Product Characteristics
Color    Score    
ShapeSize
FlavorMINTImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:61508-0526-12000 g in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product02/06/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other02/06/2017
Labeler - Germiphene Corporation (206412512)
Establishment
NameAddressID/FEIBusiness Operations
Germiphene Corporation206412512manufacture(61508-0526, 61508-0527, 61508-0528)

Revised: 2/2017
Document Id: 47a16b3b-4a8c-6446-e054-00144ff8d46c
Set id: 47a16b3b-4a8b-6446-e054-00144ff8d46c
Version: 1
Effective Time: 20170203
 
Germiphene Corporation