GENESIS SENSITIVE FRESH MINT- potassium nitrate, sodium fluoride paste 
Dr Bobs 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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Genesis Sensitive Toothpaste Fresh Mint

Drug Facts

Active ingredients

Potassium nitrate 5%

Sodium fluoride (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

  • builds increasing protection against painful sensitivity of the teeth due to cold, heat, acids, sweets or contact
  • aids in the prevention of dental cavities

Warnings

Stop use and ask a doctor if

  • the problem persists or worsens, Sensitive teeth may indicate a serious problem that may prompt care by a dentist
  • pain sensitivity still persist after 4 weeks of use 

Keep out of reach of children.

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

Directions

  • adults and children 12 years of age and older 
  • apply at least a 1-inch strip of product onto a soft bristle toothbrush 
  • brush teeth thoroughly for at least 1 minute twice a day (morning and evening), and not more than 3 times a day, or as recommended by a dentist or doctor.  Make sure to brush all sensitive areas of the teeth.  Minimize swallowing, Spit out after brushing
  • children under 12 years of age: consult a dentist or doctor

Other information

  • store below 30°C (86°F)
  • Lot No. & Exp Date: see box or see crimp of tube

Inactive ingredients

Water, Silica, Sorbitol, Sodium Lauryl Alcohol, Polyethylene Glycol 300, Sodium Carboxymethylcellulose, Flavor, Sodium Saccharin, Titanium Dioxide, Sodium Pyrophosphate, Sodium Hydroxide, PEG/PPG115/55 copolymer, Color FD&C Blue #1

​Questions or comments?

Contact customerservice@genesisbrush.com

Package Labeling:

Outer PackageInner Package

GENESIS SENSITIVE FRESH MINT 
potassium nitrate, sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71771-001
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE50 mg  in 1 g
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION1.5 mg  in 1 g
Inactive Ingredients
Ingredient NameStrength
WATER (UNII: 059QF0KO0R)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SORBITOL (UNII: 506T60A25R)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
CARBOXYMETHYLCELLULOSE SODIUM, UNSPECIFIED FORM (UNII: K679OBS311)  
METHYL SALICYLATE (UNII: LAV5U5022Y)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:71771-001-001 in 1 CARTON09/28/201701/01/2019
1113 g in 1 TUBE; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart35609/28/201701/01/2019
Labeler - Dr Bobs Inc (828669296)

Revised: 2/2020
Document Id: 9db05bc6-fcd1-6738-e053-2995a90a8ffb
Set id: e72979ac-b7d0-49a6-ab5d-3248621a9ad9
Version: 2
Effective Time: 20200203
 
Dr Bobs Inc