MedPath
FDA Approval

Sodium Fluoride 5000 ppm Enamel Protect

January 4, 2021

Human Prescription Drug Label

Sodium fluoride(5.8 mg in 1 mL)
Potassium nitrate(57.5 mg in 1 mL)

Registrants (1)

Sheffield Pharmaceuticals LLC

151177797

Manufacturing Establishments (1)

Sheffield Pharmaceuticals LLC

Sheffield Pharmaceuticals LLC

Sheffield Pharmaceuticals LLC

151177797

Products (1)

Sodium Fluoride 5000 ppm Enamel Protect

11527-745

DENTAL

January 7, 2021

Code: 8ZYQ1474W7Class: ACTIMQuantity: 5.8 mg in 1 mL
COCAMIDOPROPYL BETAINEInactive
Code: 5OCF3O11KXClass: IACT
POLYETHYLENE GLYCOL 12000Inactive
Code: VM53EE110JClass: IACT
HYDRATED SILICAInactive
Code: Y6O7T4G8P9Class: IACT
POLOXAMER 407Inactive
Code: TUF2IVW3M2Class: IACT
SODIUM LAURYL SULFATEInactive
Code: 368GB5141JClass: IACT
SODIUM HYDROXIDEInactive
Code: 55X04QC32IClass: IACT
SORBITOLInactive
Code: 506T60A25RClass: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JPClass: IACT
XANTHAN GUMInactive
Code: TTV12P4NEEClass: IACT
WATERInactive
Code: 059QF0KO0RClass: IACT
Code: RU45X2JN0ZClass: ACTIBQuantity: 57.5 mg in 1 mL
CARRAGEENANInactive
Code: 5C69YCD2YJClass: IACT
SACCHARIN SODIUMInactive
Code: SB8ZUX40TYClass: IACT
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