DOLLAR SHAVE CLUB- sodium fluoride gel, dentifrice 
Dollar Shave Club

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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Dollar Shave Club

Drug Facts

Active Ingredient

Sodium fluoride 0.24%
(0.15% w/v fluoride ion)

Purpose

Anticavity

Use

Aids in the prevention of dental cavities.

Warnings

Keep out of reach of children under 6 years of age.

If more than used for brushing is accidentally swallowed, get medical help or contact a Poison Control Center right away.

Twist off cap to remove foil seal. Do not use if safety seal is missing or broken.

Directions

Inactive Ingredients

Sorbitol, Hydrated Silica, Glycerin, Xylitol, Purified Water, Sodium Lauryl Sulfate, Flavor, Xanthan Gum, Stevia Rebaudiana Leaf Extract, Blue 1 and Yellow 10.

PRINCIPAL DISPLAY PANEL - 142 g Tube Label

SUPERBA

PEPPERMINT KICK

FLUORIDE GEL TOOTHPASTE

NET WT 5.0 OZ (142g)

PRINCIPAL DISPLAY PANEL - 142 g Tube Label
DOLLAR SHAVE CLUB 
sodium fluoride gel, dentifrice
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69522-1112
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Sodium fluoride (UNII: 8ZYQ1474W7) (fluoride ion - UNII:Q80VPU408O) fluoride ion1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
Sorbitol (UNII: 506T60A25R)  
Hydrated silica (UNII: Y6O7T4G8P9)  
WATER (UNII: 059QF0KO0R)  
Xylitol (UNII: VCQ006KQ1E)  
Glycerin (UNII: PDC6A3C0OX)  
Xanthan Gum (UNII: TTV12P4NEE)  
Sodium lauryl sulfate (UNII: 368GB5141J)  
STEVIA REBAUDIUNA LEAF (UNII: 6TC6NN0876)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
Product Characteristics
ColorGREENScore    
ShapeSize
FlavorMINT (Peppermint) Imprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69522-1112-290 g in 1 TUBE; Type 0: Not a Combination Product06/28/2018
2NDC:69522-1112-128 g in 1 TUBE; Type 0: Not a Combination Product06/28/2018
3NDC:69522-1112-3142 g in 1 TUBE; Type 0: Not a Combination Product06/28/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph finalpart35506/28/2018
Labeler - Dollar Shave Club (004164494)
Establishment
NameAddressID/FEIBusiness Operations
Lornamead126440440MANUFACTURE(69522-1112)

Revised: 6/2018
Document Id: 81fafde5-7d81-4a93-9308-b39eaaa4abe2
Set id: af824de9-172e-48b6-8cb0-f78a08bf21a6
Version: 1
Effective Time: 20180607
 
Dollar Shave Club