IODENT SENSITIVE- potassium nitrate,sodium fluoride paste 
Zhaoqing Longda Biotechnology Co., Ltd.

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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72129 002 Potassium Nitrate Sodium Fluoride

Active Ingredient

Potassium Nitrate 5%

Sodium Fluoride . 0.15%

Purpose

Antihypersensitivity

Anticavity

Use

Builds increasing protection against painful sensitivity of the teeth due to cold , heat , acids, sweets or contact.

Aids in the prevention of dental cavities

Warning

Stop use and ask a dentist if

The problem persists or worsens. Sensitive teeth may indicate a serious problem that may prompt care by a dentist

Pain/sensitivity still persists after 4 weeks of use

Directions

Adults and children 12 years of age and older

Apply at least at 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

Inactive Ingredients

calcium carbonate , water, sorbitol , silica, polyethylene glycol 400, sodium laury alcohol, sodium carboxymethyl cellulose, flavor, sodium saccharin, methylparaben, propyparaben , sodium hydroxide

Keep out of reach of children under 6 years of age

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

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IODENT SENSITIVE 
potassium nitrate,sodium fluoride paste
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:72129-002
Route of AdministrationDENTAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.15 g  in 100 g
POTASSIUM NITRATE (UNII: RU45X2JN0Z) (NITRATE ION - UNII:T93E9Y2844) POTASSIUM NITRATE5 g  in 100 g
Inactive Ingredients
Ingredient NameStrength
SODIUM PYROPHOSPHATE (UNII: O352864B8Z)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
WATER (UNII: 059QF0KO0R)  
SODIUM SILICATE (UNII: IJF18F77L3)  
SODIUM HYDROXIDE (UNII: 55X04QC32I)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
POLYETHYLENE GLYCOL 300 (UNII: 5655G9Y8AQ)  
SODIUM CARBOXYMETHYL .BETA.-GLUCAN (DS 0.65-0.85) (UNII: 2YGO1190AP)  
POTASSIUM SODIUM SACCHARATE (UNII: 73U34YC90U)  
SORBITOL (UNII: 506T60A25R)  
PEG/PPG-116/66 COPOLYMER (UNII: JP0CK963E0)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:72129-002-0124 in 1 BOX02/02/2018
112 in 1 PACKAGE
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 finalpart35602/02/2018
Labeler - Zhaoqing Longda Biotechnology Co., Ltd. (546452557)
Establishment
NameAddressID/FEIBusiness Operations
Zhaoqing Longda Biotechnology Co., Ltd.546452557manufacture(72129-002)

Revised: 2/2022
Document Id: d80b4544-0e75-218b-e053-2a95a90a5005
Set id: 65ce884d-8106-30ac-e053-2991aa0ab486
Version: 2
Effective Time: 20220215
 
Zhaoqing Longda Biotechnology Co., Ltd.