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FDA Approval

PreviDent 5000 Enamel Protect

CompanyColgate Oral Pharmaceuticals, Inc. (DUNS: 968801118)

Effective Date

August 17, 2022

Labeling Type

HUMAN PRESCRIPTION DRUG LABEL

Active Ingredients

Sodium fluoride(5.8 mg in 1 mL)

Potassium nitrate(57.5 mg in 1 mL)

Products (1)

PreviDent 5000 Enamel Protect

NDC Product Code

0126-0022

Route of Administration

DENTAL

Effective Date

August 17, 2022

Ingredients

Sodium fluorideActive

Code: 8ZYQ1474W7Class: ACTIMQuantity: 5.8 mg in 1 mL

Potassium nitrateActive

Code: RU45X2JN0ZClass: ACTIBQuantity: 57.5 mg in 1 mL

XANTHAN GUMInactive

Code: TTV12P4NEEClass: IACT

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