SENSITIVE ANTI-CAVITY- potassium nitrate and sodium fluoride paste 
Universal Distribution Center LLC

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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SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

Active Ingredients

Potassium Nitrate  5%

Sodium Fluoride (0.15% w/v fluoride ion)

Purpose

Antihypersensitivity

Anticavity

Uses

Warning

When using this product

Stop and ask a dentist

Sensitivity teeth may indicate a serious problem that may need prompt care by a dentist.

Keep out of reach of children

Directions

Adults and Children 12 years of age and older:

Children under 12 years of age: Consult a dentist or doctor.

Other information

Inactive Ingredients

D&C yellow#10, FD&C blue#1, flavor, glycerin, methylparaben, poly ethylene glycol 1500, propylparaben, silica, sodium benzoate, sodium carboxy methyl cellulose, sodium lauryl sulfate, sodium saccharin, sorbitol, titanium dioxide, treated water, tri sodium ortho phosphate.

PRINCIPAL DISPLAY PANEL

SENSITIVE ANTI-CAVITY FLUORIDE TOOTHPASTE

label

SENSITIVE ANTI-CAVITY 
potassium nitrate and sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52000-037
Route of AdministrationORAL
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
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
GLYCERIN (UNII: PDC6A3C0OX)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYETHYLENE GLYCOL 1500 (UNII: 1212Z7S33A)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
CARBOXYMETHYLCELLULOSE SODIUM (UNII: K679OBS311)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
SORBITOL (UNII: 506T60A25R)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52000-037-471 in 1 BOX06/21/2017
1122 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 finalpart35606/21/2017
Labeler - Universal Distribution Center LLC (019180459)
Registrant - Universal Distribution Center LLC (019180459)
Establishment
NameAddressID/FEIBusiness Operations
Yangzhou Holyshine Industrial Co. Ltd421141948manufacture(52000-037)

Revised: 6/2017
Document Id: 527d601e-591a-38fb-e054-00144ff8d46c
Set id: 5f281214-4348-4d6e-88ed-f9ab77b97de0
Version: 1
Effective Time: 20170621
 
Universal Distribution Center LLC