NeutraGard Gel Strawberry
NeutraGard Gel Strawberry
Approved
Approval ID
80b21d06-35fa-6a4a-e053-2991aa0a5f6c
Product Type
HUMAN PRESCRIPTION DRUG LABEL
Effective Date
Jan 30, 2019
Manufacturers
FDA
Pascal Company, Inc.
DUNS: 009260217
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
Topical neutral fluoride gel
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
NDC Product Code10866-0117
Product Classification
G
Generic Name
Topical neutral fluoride gel
Product Specifications
Route of AdministrationDENTAL
Effective DateJanuary 30, 2019
FDA Product Classification
INGREDIENTS (5)
EDETATE CALCIUM DISODIUMInactive
Quantity: 1 mg in 1 g
Code: 25IH6R4SGF
Classification: IACT
SACCHARIN SODIUMInactive
Quantity: 2.5 mg in 1 g
Code: SB8ZUX40TY
Classification: IACT
CETYLPYRIDINIUM CHLORIDEInactive
Quantity: 0.1 mg in 1 g
Code: D9OM4SK49P
Classification: IACT
SODIUM FLUORIDEActive
Quantity: 7 mg in 1 g
Code: 8ZYQ1474W7
Classification: ACTIM
CARBOMER HOMOPOLYMER TYPE CInactive
Quantity: 18.5 mg in 1 g
Code: 4Q93RCW27E
Classification: IACT